Clinical Scientist Job Description

A Clinical Scientist makes sure a drug trial asks the right scientific questions. In biopharmaceutical development, the position sits inside clinical development teams under a medical director, and it owns the scientific rationale behind protocols, investigator brochures, and the clinical sections of IND filings and study reports. The hard part is judgment. Trial data arrive continuously from phase 2 and phase 3 studies run under ICH-GCP, and the Clinical Scientist must decide which safety signals, outliers, and endpoint trends deserve escalation long before a formal Go/No-go decision reaches the program team.

As the Clinical Scientist, you will turn program strategy into scientifically sound trial designs and defensible clinical data, giving leadership the evidence it needs for regulatory filings and investment decisions on each molecule. You will work within a clinical development program alongside project physicians, biostatisticians, and clinical operations, typically reporting to a Senior Medical Director or Clinical Research Director.

Career Impact: Authorship on investigator brochures, CSRs, and peer-reviewed manuscripts gives you a portfolio of regulatory-grade work that drug developers screen for directly.

Business Impact: Your protocol rationale and data review determine how cleanly a late-stage program's endpoints hold up in front of an FDA Advisory Committee.

Growth Opportunity: Repeated exposure to IND preparation and late-stage readouts prepares you for Study Responsible Clinical Scientist and Clinical Science Leader responsibilities.

Company Value: Employers in this space often organize the work around patient and stakeholder centricity, with a one-team model linking biostatistics, medical affairs, and regulatory.

• Design protocol concepts, synopses, and full protocols, owning scientific rationale for endpoints, scales, and laboratory assessments.
• Review ongoing clinical trial data to identify trends, outliers, and integrity issues requiring escalation to the study team.
• Partner with the Medical Monitor on safety reviews, adverse event evaluation, and drafting of adverse event narratives.
• Develop clinical study reports, investigator brochures, DSURs, and clinical sections of IND and regulatory briefing documents.
• Collaborate with biostatisticians on statistical analysis plans, case report forms, and data collection tools for each study.
• Coordinate with Clinical Operations, CROs, and vendors on feasibility, site selection, and study execution issues.
• Guide abstracts, posters, and manuscripts presenting clinical study data in line with the product publication plan.
• Monitor scientific literature and the competitive clinical landscape to inform protocol design and development planning.

• Bachelor's degree in life sciences or a related scientific field or equivalent work experience.
• 3 or more years of clinical development experience, with direct involvement in industry-sponsored clinical trials.
• Working knowledge of ICH-GCP guidelines and regulatory requirements governing clinical trials, IND content, and marketing filings.
• Understanding of clinical trial design, study endpoints, and statistical concepts sufficient to shape analysis plans.
• Ability to critically interpret scientific literature and clinical data and translate findings into written reports.
• Strong scientific writing skills for protocols, clinical study reports, abstracts, and regulatory documents intended for health authorities.
• Ability to work within cross-functional matrix teams and influence physicians and operations colleagues without direct authority.
• Proven capacity to manage multiple studies, priorities, and competing deadlines in a changing drug development environment.

• Advanced degree such as PhD, PharmD, MD, or MSc in a life science or clinical discipline.
• Oncology or immunology therapeutic area experience, particularly in late-stage or early translational development programs.
• Hands-on contribution to regulatory submissions or Health Authority interactions, including responses to agency questions.
• Experience co-authoring peer-reviewed publications and presenting clinical data at investigator meetings or scientific conferences.

• Protocol amendment count per study, reflecting how sound the original scientific design was.
• Days from database lock to CSR draft, tracking clinical reporting turnaround.
• Open data queries aged over 30 days, showing thoroughness of ongoing data review.
• Health Authority questions on authored sections, measuring clarity of clinical documentation.
• Publications and abstracts accepted per year, reflecting dissemination of study results.

• Base Salary Range: $120,000 to $165,000 for mid-level biopharma clinical scientists
• Bonus: Annual target bonus of 10% to 15% of base salary
• Equity: RSUs or stock options, common at biotech and emerging pharma companies
• Health Benefits: Medical, dental, and vision coverage with HSA or FSA options
• PTO: 15 to 25 days plus company holidays and year-end shutdown
• Common Perks: 401(k) match, conference travel, continuing education, and hybrid schedules

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level

Offers of employment are contingent on a successful background check, which may include verification of education and prior clinical research roles and, where required, drug screening. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by federal, state, or local law. Reasonable accommodations are available on request throughout hiring. Candidates must be authorized to work in the United States.

The Clinical Scientist owns scientific responsibility for assigned international clinical trials, co-leading projects, calibrating the clinical team through rater training, and safeguarding scientific integrity across study analyses. Reporting to clinical leadership and working with sponsors, Business Development, and key opinion leaders, the Clinical Scientist ensures study metrics stay on track and sponsors receive clear, credible scientific support.

Key Responsibilities

• Act as external facing clinical representative responsible for the independent clinical management of international clinical trials.
• Own scientific responsibility and co-lead each assigned project, along with accountability for ensuring that the scientific integrity is maintained and all necessary analyses and remediations are conducted and effectively communicated.
• Actively participate in internal and external project meetings (e.g., weekly external client call, Investigators' Meetings).
• Review, monitor, and proactively address issues regarding study level metrics, and present study dashboards to sponsors by reviewing data, any outliers or areas of concern, as well as any actions taken to address these concerns.
• Resolve clinical quality or training related issues.
• Calibrate the clinical team, conduct rater training events, and remediations as specified in the study-specific training plans.
• Provide scientific support to external and internal stakeholders, leveraging strong communication and negotiation skills and strategies.
• Respond to and resolve external inquiries regarding company scoring or feedback.
• Communicate with all internal stakeholders and coordinate resources to meet project objectives.
• Assist with or take responsibility for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.).
• Work with Business Development to review potential studies, RFPs, as needed.
• Develop and nourish peer-to-peer relationships with external consultants, key opinion leaders, and Clinicians, both regionally and in research areas of interest.
• Actively participate in research and publications efforts and report research results externally through peer-reviewed journals, conferences, or other appropriate venues.
• Identify the need for and contribute to the development of departmental and cross-disciplinary work instructions, process guidelines and standard operating procedures to ensure all processes and procedures meet SOP/GCP requirements.

Required Qualifications

• Graduate degree in a life science discipline or other field relevant to the company's business focus.
• 5 years of experience in the clinical research industry, with experience working for a biopharmaceutical sponsor or a clinical research organization preferred.
• Minimum 3 years of experience as a clinical scientist, clinical trial science lead or similar role with client-facing scientific responsibilities.
• Minimum 4 years of experience with the administration of rating scales with practical knowledge of study endpoints as part of sponsored clinical research.
• Strong understanding of Good Clinical Practice (GCP).
• Solid understanding of basic and intermediate research methods and statistics.
• Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.
• Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
• Ability to lead through influencing and negotiating, with demonstrated leadership skills and ability to integrate in a team, motivate others and communicate clearly and effectively.
• Strong problem solving/decision making skills, demonstrated by ability for independent critical thinking, solution generation and engagement in active scientific exchange.
• Strong communication and negotiation skills across audiences with a demonstrated ability to assess complex situations and devise impact-generating solutions based on incomplete data.
• Demonstrated ability to present in front of large audiences from varied backgrounds requiring the ability to tailor the discussion to meet their needs.
• Fluent in English, with bi-lingual or multi-lingual skills preferred.

Embedded within Global Clinical Development, the Clinical Scientist leads the development of Medical Monitor Plans, protocol synopses, and investigator brochures while performing ongoing review and critical analysis of study data. Working closely with clinical research physicians, biostatisticians, and programmers, the Clinical Scientist turns literature reviews and competitive insight into strategic input that strengthens protocol design, regulatory documents, and publications for the company's drug candidates.

Core Functions

• Lead development of Medical Monitor Plans.
• Perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician in pharmacovigilance data reviews.
• Provide support as needed for clinical and scientific issues that may arise during study execution.
• Work closely with biostatisticians and programmers to plan analyses of clinical data.
• Support data outputs for Board meetings, analyst events.
• Lead the development of clinical study protocol synopses, full protocols and investigator brochures.
• Contribute in the writing and review of clinical study reports (CSRs), data safety update reports (DSURs) and annual reports and regulatory briefing books.
• Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data and participate in publication planning.
• Contribute towards writing of departmental working processes (SOPs, templates, etc).
• Assist clinical research physician in developing clinical development plans.
• Contribute to the development of data collection tools, statistical analysis plans (SAPs), case report forms (CRFs).
• Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
• Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied.
• Identify and review literature that addresses specific topics of interest relevant to company drug candidates.

Qualifications & Experience

• Advanced, doctoral level degree preferred such as PhD, MD, MSc/MPH, PharmD.
• BS/MS with equivalent relevant working experience may be considered.
• 5+ years of experience within a pharmaceutical company environment.
• Oncology/Neurology disease experience preferred.
• Experience in conducting clinical trials.
• Basic knowledge of GCP/ICH, drug development process, study design, and statistics.
• Excellent project management, communication and organizational skills with demonstrated success in leading projects and interacting with cross functional teams.
• Passionate commitment and a strong team player.
• Understanding of the impact of decisions and ability to function successfully across a variety of projects, and manage change in a dynamic environment.
• Proven expertise in the proactive identification of issues, coupled with the ability to contribute to solutions affecting cross-functional teams.
• Demonstrated ability to work independently, as well as equally able to take direction/instruction from others and reliably deliver objectives of high quality in a timely manner.

Reporting to clinical development leadership, the Clinical Scientist shapes clinical strategy and trial design by owning the scientific rationale of protocols, from methods and scales to labs, within a dermatology-focused program. Partnering with CROs, vendors, scientific writers, and thought leaders, the Clinical Scientist supports regulatory documentation and study reports that move systemic agents toward Health Authority review.

Primary Duties

• Coordinate study design and Protocol development with team members to address scientific questions.
• Own scientific aspect/rationale of the protocol (i.e. methods, scales, labs, etc.) and contribute to clinical section of development plan and/or protocol(s) in collaboration with other clinical study team members.
• Coordinate with team members to address scientific questions related to planned or ongoing clinical trials, in liaison with relevant staff at CRO(s) and vendors as applicable.
• Support the scientific aspects of the clinical study and review data trends through risk based monitoring tool.
• Support the development of the Clinical Study Report (CSR), in collaboration with the scientific writer or others.
• Contribute to the preparation of regulatory documentation (Briefing Packages, Investigator's brochures, IND/IMPD, labelling documents etc.), and answer to questions from Health Authorities during the review process etc.
• Assist with organizing, managing and conducting Scientific Advisory Boards and KOL reviews.
• Develop, research and maintain current and future competitive clinical landscape(s).
• Identify clinical thought leaders within the appropriate therapeutic area to establish relationships and provide scientific outreach within the dermatological specialty community.
• Contribute to the selection of vendors, countries and trial investigators.
• Prepare and review SOPs, and contribute to process improvement initiatives, as deemed appropriate.

Skills & Qualifications

• Bachelor's degree in Life Sciences, Engineering or related field.
• Master's degree, PhD or Medical Doctor preferred.
• 4-7 years of relevant experience in clinical research and development in the pharmaceutical industry and/or in a Contract Research Organization (CRO).
• Experience in the scientific aspects of design and conduct of large and/or complex phase 2/3 clinical trials preferred.
• Proven experience in supporting development of systemic agents (large or small molecules).
• Fluency with GCP and ICH guidelines.
• Experience with risk-monitoring systems preferred.
• Fluent in English (written and oral).

Sitting at the intersection of evidence generation and clinical practice, the Clinical Scientist builds and explores research questions on mental health conditions and their treatment, applying coding, data cleaning, and statistical analysis to therapy delivery and clinical trials data. Operating across the Evidence & Impact, AI, and Clinical teams, the Clinical Scientist generates insights that inform product development, service improvements, and trial design, with findings shared internally and in peer-reviewed journals.

Duties

• Identify key research questions that meet the company's business needs.
• Contribute and take ownership of new research ideas and explore research questions aimed at improving our knowledge of mental health conditions and the effectiveness of mental healthcare.
• Be involved in the development and design of clinical trials and research studies.
• Plan and contribute to best practice in responsible innovation (e.g., ethics, engaging with lived experience).
• Deliver research projects in a timely and efficient manner.
• Perform coding, cleaning and statistical analysis of therapy delivery and clinical trials data.
• Produce effective written summaries and documentation of work.
• Disseminate findings to team members, the wider company and externally.
• Provide transparent written reporting of work that clearly conveys what has been done and what the implications are.
• Prepare materials for data dissemination, including internal presentations, conferences, and manuscripts for publication in peer-reviewed journals.

Requirements

• Undergraduate degree in psychology, other life or social sciences, or any quantitative discipline employing statistical analysis methods.
• Experience with publishing in peer-reviewed journals.
• Knowledge and experience of relevant statistical and research methods.
• Experience with R as a statistical analysis tool.
• A curious mind and desire to learn.
• Ability to work well independently and in a team.
• Analytical mindset with excellent written and verbal communication skills.
• Ability to work in a time-efficient way based on a can-do attitude.

A key member of the clinical affairs team, the Medical Device Clinical Scientist delivers clinical expertise for cardiovascular studies, establishing scientific methods for protocols, investigator's brochures, and sponsor ICFs. Collaborating across investigators, CROs, hospitals, and regulators such as PMDA, the Medical Device Clinical Scientist guides trials and registries from initiation to completion and supports sound regulatory submissions.

Functions

• Plan clinical affairs projects and activities with accountability for successful completion within scope of project deliverables.
• Provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, investigator's brochure, sponsor ICF, and reports/data presentations/publications.
• Prepare documentation for regulatory submissions required in the local market and other counties (if requested), and communicate with PMDA from the perspective of clinical science.
• Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/registries from initiation through completion.
• Identify and evaluate clinical affairs process improvements and/or course correction/course alignment opportunities.

Experience & Qualifications

• Bachelor's Degree in scientific or related field with extensive clinical trial experience in the cardiovascular area.
• Comprehensive record of delivering research information which adds value to management decision making process.
• Understanding of and compliance with all current applicable regulations, ICH Good Clinical Practice (GCP), ISO 14155 and Company operating procedures, processes, policies, and tasks.
• Proven expertise in Microsoft Office Suite, including advanced Excel.
• Experience with CTMS and electronic document management systems a definite plus.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Ability to perform in a diverse cross-functional team environment and converse effectively with all levels of employees, management, and customers.
• Fluency in Japanese, business level English.

Translating image guided therapy innovation into hospital practice depends on the Clinical Scientist, who builds partnerships with medical doctors to evaluate new clinical applications for IGT imaging systems and devices. Serving as a bridge between clinical sites, marketing, sales, service, and product development, the Clinical Scientist supplies clinical requirements and helps customers publish high-quality research that strengthens the IGT portfolio.

Accountabilities

• Collaborate with medical doctors in local hospitals in evaluating new clinical applications for IGT imaging technics and devices.
• Keep up to date with innovations in IGT imaging system and IGT devices via scientific literature, symposia and local/international conferences.
• Assist customers in local hospitals/universities/other research institutes to develop and publish HQ papers on conferences and journals.
• Develop in-depth knowledge on IGT imaging system and IGT devices.
• Advise colleagues in Product/Solution marketing and Applications on new technical and clinical developments, and assist in writing commercial and technical documents.
• Provide clinical requirements and support to product development.
• Advise colleagues in Sales and Service department on new clinical and technical developments.
• Regularly visit Clinical Science sites in the region and discuss innovations with medical doctors.
• Support solution creation and co-creation with 3rd parties for IGT.

Technical Qualifications

• PhD degree in medical, medical science, biomedical engineering, physics or other imaging guided therapy relevant technical background (fresh graduates are also welcomed).
• MS degree with above 2-5 years imaging guided therapy relevant research experiences.
• Experience in clinical study set up and execution.
• Strong communication skills (clinical and technical) and teamwork.
• Ability to create trust, build and maintain relationships, connect and inspire.
• Strong problem solver capability and business orientation.
• Strong capacity to learn and apply advanced knowledge.
• Good leadership and project management skills.
• Good writing skills (Chinese and English).

As the Clinical Scientist, this role owns the selection, qualification, training, and monitoring of more than 30 external PBMC processing labs supporting clinical trials, serving as the subject matter expert on PBMC isolation. The project team relies on this work to keep sample inventories accurate, laboratories supplied, and experimental results compliant with cGMP/GLP requirements.

Activities

• Exercise and build basic team effectiveness skills (e.g., commitment, feedback, consensus management) within the immediate work group.
• Perform job responsibilities in compliance with current Good Manufacturing Practices/Good Laboratory Practice (cGMP/GLP) and all other regulatory agency requirements.
• Select, qualify, train, and monitor PBMC processing labs in support of clinical trials.
• Become an SME (subject matter expert) related to PBMC isolation and management of external laboratories.
• Review processing forms and sample inventory files from 30+ external laboratories and ensure all labs are supplied with all necessary consumables and reagents.
• Prepare and present experimental results to project teams.
• Comply with all safety training and good laboratory practices.

Position Requirements

• Bachelor's Degree.
• Master's degree and 4+ years of relevant experience.
• 6+ years of pharmaceutical and biotech drug discovery experience.
• Experience in lab management and clinical trial monitoring, with CRO and vendor oversight experience preferred.
• Strong background in immunology, microbiology (bacteriology or virology).
• Technical expertise in PBMC isolation and supporting clinical trial activities.
• Ability to use appropriate software to perform analysis of data.
• Excellent organization and planning skills, the ability to work in a fast-paced environment independently or as part of a team, strong motivation with a dedicated work ethic.
• Excellent verbal and written communication skills.
• Ability to perform physical activities such as standing or sitting at the lab bench or biosafety cabinet and focus on computer screen for several hours per day.

Clinical Scientist shapes the clinical evidence base for in vitro diagnostic products, producing Scientific Validity Assessments and Clinical Performance reports that demonstrate clinical benefit and safety under the IVD-Guidelines. The work directly supports Regulatory, Clinical Operations, Lifecycle, and R&D teams, as well as Global Clinical Leaders, by defining intended uses, closing evidence gaps, and improving Medical and Scientific Affairs workflow quality.

Operational Focus

• Collaborate with Regulatory, Clinical Operations, Lifecycle teams, and R&D to produce Scientific Validity Assessments, Clinical Performance reports, and assist in the development of product needs and specifications rendering to the IVD-Guidelines (in vitro diagnostics).
• Record proof of training rendering to SOP 'Mitarbeiterentwicklung / Employee Development'.
• Assist Global Clinical Leaders (GCL) and Clinical Science Leaders (CSL) in the evaluation and description of Intended Uses (IU) and clinical testing purposes of CPS products.
• Guarantee consistent improvement of Medical and Scientific Affairs workflow to increase effectiveness and quality.
• Examine clinical evidence in medicine connected to the CPS products and IUs to demonstrate clinical benefit and safety.
• Optimise procedures to increase quality and competence standards.
• Operate proactively alongside CPS and international functions to assess products of the CPS portfolio concerning clinical evidence needs rendering to the IVD-Guidelines across all indication fields and evolve tactics to fill eventual evidence gaps.

Knowledge Skills & Abilities

• Educated to an advanced degree level in a biomedical, public health, epidemiological or medical discipline.
• At least 3-5 years of experience in clinical research, ideally in Oncology.
• Experience with IVD ideal.
• Data analysis capabilities.
• Computer literacy in MS Office, gSuite, etc.
• Keen to learn with a positive and open mentality.
• A novel outlook and spirit.
• Communication skills both verbally and in writing.
• Ability to work well in a team setting.
• Fluency in the English language.

The Clinical Scientist advances new and existing swine vaccines by designing experiments, conducting virology and bacteriology tests, and writing protocols and reports suitable for regulatory submission. Reporting to project team leadership while training junior staff, the Clinical Scientist helps validate and transfer assays and manufacturing processes that keep veterinary vaccine development compliant and on schedule.

Key Deliverables

• Contribute to the development of new and existing swine vaccines through membership in project teams, as appropriate to the role and required by the business.
• Perform experiments independently in the realm of virology/bacteriology and clinical trials.
• Conduct microbiological analytical tests to identify microbiological characteristics in phenotype and genotype.
• Apply advanced technical and functional knowledge to the design of experiments for the development of swine vaccines.
• Write protocols, reports, and technical documents suitable for regulatory submission in a timely manner.
• Lead or attend develop, validate and transfer assays and manufacture processes.
• Train/supervise junior staffs, such that they perform as expected.
• Participate in the non-project activities to ensure compliant and smooth lab operation.
• Actively contribute to team discussions.

Professional Experience

• Master degree in a relevant field (Virology/bacteriology, Veterinary Science, Immunology or other relevant disciplines) or several years of direct experience in swine vaccine development.
• Ability to apply clinical and scientific knowledge to the development of veterinary vaccines.
• Ability to collate and present study data.
• Attention to details, team player, good organizing skills.
• Ability to prioritize tasks of low to medium complexity.
• Ability to communicate in English.
• Willingness to work flexible hours and travel as required.

Embedded within the clinical diagnostic lab, the Clinical Scientist refines laboratory processes by troubleshooting non-conformances, mapping process risks, and building tools that monitor lab performance. Working closely with Operations management, Technical Development, and Quality Engineering, the Clinical Scientist confirms root causes, implements corrective actions, and brings new products and processes into production laboratories with fewer failures and stronger quality assurance.

Areas of Ownership

• Aid in developing and implementing tools to monitor the performance of lab processes.
• Aid in process mapping and risk assessment for any new processes being implemented, as well as in process mapping and risk evaluations to better understand the current lab process and potential areas of improvement.
• Identify continuous improvement projects with Operations management based on performance data and process evaluation discussions.
• Aid in troubleshooting non-conformances to identify root cause, especially when they impact more than one department.
• Serve as an escalation point for lab groups to help resolve local area problems.
• Work with Project Management as a key technical resource in cross-functional project teams and participate in large project/validation teams for new products and processes.
• Serve as a trainer or mentor on technical processes for Operations laboratories.
• Participate in the laboratory's quality assurance plan, adhere to all regulatory policies, and appropriately document all activities.
• Follow the laboratory's policies and procedures whenever test systems are not within acceptable limits and document the problem and any corrective action.
• Complete training and competency assessment successfully and in a timely manner as outlined in the laboratory and departmental training programs.
• Participate in continuing education according to accepted laboratory standards.

Education & Experience

• High school diploma or equivalent.
• Doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology.
• Associate's degree in a laboratory science or medical laboratory technology.
• At least 90 semester hours including 16 semester hours of chemistry including at least 6 semester hours of inorganic chemistry, 16 semester hours of biology, 3 semester hours of math.
• Completion of a clinical laboratory training program approved or accredited by the ABHES, CAHEA or other HHS approved organization (this training may be included in the 60 semester hours listed above).
• Graduation from a MT program.
• Completion of a military MT training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Lab technician).
• At least 3 months lab training in each specialty in which the individual performs high complexity testing.

Reporting to clinical team leadership, the Clinical Scientist develops clinical development plans, trial protocols, and case report forms for a molecular entity, while evaluating adverse events and drafting safety narratives. Partnering with Study Responsible Clinical Scientists, physicians, and Clinical Operations, the Clinical Scientist prepares study reports and filing documents that support marketing authorization.

Role Responsibilities

• Support activities related to the design, execution, monitoring, and reporting of clinical trials.
• Support preparation of clinical development plans, trial protocols, case report forms, study operational plans.
• Support medical monitoring activities and reporting in partnership with Study Responsible Clinical Scientist and Study Responsible Physician, evaluate clinical trial adverse events, review clinical laboratory results, and draft adverse event narratives.
• Partner with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting.
• Assist Data Management with the review of clinical data and query resolution.
• Work closely with Quality Management and Assurance to ensure flawless execution of clinical trials.
• Support completion of clinical study reports.
• Support responses to questions from Ethics Committees and Health Authorities.
• Support integrated document development for marketing authorization filing and preparation for the FDA Advisory Committee and EU Oral Explanation.
• Review medical literature and related new technologies.

Background & Experience

• BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field.
• 5 years industry experience or equivalent clinical research experience.
• Experience in late-stage drug development, with experience in immuno-inflammatory indications preferred.
• Ability to survey and interpret the scientific literature related to the assigned projects.
• Proficient with Microsoft Office applications EXCEL, POWERPOINT, and WORD.
• Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
• Ability to work in a global matrix organization with cross-functional teams.
• Excellent written and verbal English communication skills.

Sitting at the intersection of cognitive neuroscience and commercial client work, the Clinical Scientist produces scientific proposals and consultancy that help pharma and biotech clients make the best use of cognitive assessments in schizophrenia studies. Operating across scientific, product development, business development, and global sales teams, the Clinical Scientist analyses cognitive data for reports and publications, keeping assessment quality high and client trials scientifically sound.

Job Functions

• Consult pharma/biotech clients comfortably on aspects relating to cognition in Schizophrenia (SZ) and ensure best use of our products in their studies.
• Work collaboratively alongside scientific, product development and global sales teams to develop solutions to commercial and practical challenges faced by our clients.
• Advise our business development team on use of cognitive tests in a study or trial.
• Write effective scientific proposals for clients that meet the needs of the clients.
• Provide continued scientific support for clients throughout trials.
• Provide support for collaborative Science/R&D projects.
• Analyse cognitive data for reports, publications and presentations and present these findings.
• Provide scientific consultancy to clients and scientific leadership internally.
• Work independently or in collaboration with other company Scientists on client projects and in conjunction with our Research and Development and Product Teams to maintain and improve the high quality of our cognitive assessments.
• Share knowledge within the company and with clients and keep abreast with developments in the field.

Required Qualifications

• PhD or MSc in a cognition/neuroscience or related subject (ideally with Schizophrenia focus).
• Demonstrable experience of assessing cognition in patients with Schizophrenia.
• Demonstrable experience in providing scientific consultancy.
• Experience in the commercial, clinical trials, pharma or biotech sector desirable.
• Current knowledge of SZ literature and applied cognitive neuroscience literature.
• Understanding of statistical principles.
• Familiarity with SPSS, R, Python or SAS.
• Ability to think creatively about the use of our products to meet client needs.
• Excellent communication and interpersonal skills.
• Ability to juggle multiple projects and engage with internal and external stakeholders as required.

A key member of Clinical and Medical Affairs, the Clinical Scientist oversees radiation oncology physics research by generating scientific evidence through experiments, test data analysis, and article writing for a novel radiotherapy system. Collaborating across R&D, institutional partners, and KOLs, the Clinical Scientist translates research into conference presentations and publications that support clinical adoption.

What You'll Do

• Focus day-to-day tasks on generating scientific evidence through experiments, data aggregation and article writing.
• Collect and analyse test data.
• Demonstrate good writing and scientific presentation skills.
• Work with institutional partners on projects that can lead to conference presentation and publication.
• Support medical affairs and marketing initiatives including presenting to customers, requesting scientific proposal and other customer facing activities.
• Work across the organization on cross-functional projects as applicable.
• Support the development of software for pre-clinical development research.

Qualifications & Experience

• MS/PhD in medical physics, physics, biomedical engineering, or closely related field.
• MSc with < 2 years (Associate Clinical Scientist) or MSc with +2 years/PhD (Clinical Scientist) research experience in industry or academic setting.
• Hands-on experience on the novel BgRT system.
• Knowledge of radiotherapy industry.
• Software design skills and programming expertise using Matlab, Python, and C++.
• EGSnrc or GEANT4 Monte Carlo simulation skill an added advantage.
• Ability to interact with clinical customers such as physician, medical physicists, and research collaborators.
• Ability to travel up to 30% domestically and internationally.

Successful execution of respiratory clinical studies depends on the Clinical Scientist, who develops high quality clinical documents for study use and regulatory submission while acting as an associate clinical monitor on protocol, SAP, and ongoing data review. Based within the Respiratory Program and reporting to the Director, Clinical Research, the Clinical Scientist partners with clinical pharmacology, regulatory, and clinical operations to inform Go/No-go decisions.

Day-to-Day Responsibilities

• Act as an associate clinical monitor under the supervision of the Medical Director/Medical Monitor for assigned product development programs, including support for design and conduct of clinical trials (i.e. protocol and SAP development, ongoing data review, response to IRB/MoH queries).
• Provide direction and liaise with clinical operations to ensure successful execution of clinical studies.
• Act as clinical representative on study teams, development teams and at interdepartmental meetings to discuss progression and execution of clinical programs.
• Develop, draft and/or review clinical study reports and help to manage the presentation of key clinical findings to internal and external stakeholders.
• Support critical interpretation of results of completed clinical trials for important Go/No-go decisions and in preparation for submission to relevant regulatory authorities.
• Draft and develop documents for assigned development programs (i.e. briefing books for advisory boards or regulatory meetings, clinical development plans).
• Contribute to annual updating of product Investigator Brochures.
• Research published literature and regulatory documents related to clinical development plans, protocol development and execution and other scientific activities of the department.
• Assess literature and disease background for in-licensing opportunities.
• Support creation of in-house medical training and investigator meeting materials.
• Conduct trainings for internal and/or external study personnel to support ongoing studies (IB, protocol, therapeutic area, etc.).
• Support advisory board meetings including development of meeting materials, and in general, work with external advisors as needed to support ongoing programs.
• Assist with conceptualization, review and authoring of abstracts, posters and manuscripts to support the product publication plan, and lead effort as appropriate.
• Contribute to the scientific, clinical, and commercial development of product candidates (both internal and external), including medical and scientific input for due-diligence processes and presentation of key findings.

Skills & Qualifications

• Industry experience with study design, conduct and finalization of study reports a strong plus.
• Basic knowledge of clinical trial design, biostatistics, clinical pharmacology, pharmacokinetics, with familiarity with infectious diseases a plus.
• Ability to independently conduct review of literature and present in depth scientific analysis of published literature.
• Ability to author abstracts and contribute to scientific publications.
• Ability to hold a dialogue regarding the most current scientific and/or medical thinking.
• Ability to adopt new techniques within the discipline.
• Ability to plan and carry out clinical trials with supervision.
• Ability to independently solve routine problems within discipline and exercise independent judgment to determine and recommend appropriate actions within the discipline.
• Recognition of appropriate opportunities to apply skills and share clinical insight across the organization.
• Strong written and verbal communication skills, able to articulate complex concepts to internal and external team members and contribute to authoring reports, SOPs, regulatory filings, or other relevant documents.
• Ability to work in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

As the Clinical Scientist, this role oversees global clinical trial delivery, translating scientific imperatives into operational plans and leading the cross-functional Study Conduct Team from feasibility and site initiation through close-out. The clinical development organization relies on this work to keep vendors, sites, and drug supply coordinated, data quality high, and studies inspection-ready for regulatory filing.

Scope of Work

• Support study design, translate scientific imperative into operational delivery of trials, and review and/or write study concept, protocol, study plans, IP management plans, CSRs.
• Lead the cross-functional Study Conduct Team, drive operational delivery and facilitate issue resolution.
• Plan timelines, conduct study feasibility, risk assessment/management and contingency planning, and ensure timelines are communicated to all personnel assigned to the study (including vendors).
• Plan and/or conduct site evaluation and initiation, and develop and maintain effective relationships with clinical sites globally.
• Provide guidance on protocol and procedures in the development of eCRF design.
• Review monitoring visit reports and liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions.
• Review clinical trial data, monitor data quality and ensure appropriate quality measures are in place.
• Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing.
• Interact and coordinate with study specific vendors.
• Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects.
• Maintain TMF and ensure inspection readiness.
• Manage stakeholders proactively and communicate progress and issues.

Requirements

• Substantial industry-sponsored clinical trial management experience, with experience with biologics or cell and gene therapy a plus.
• Project experience leading cross-functional teams in a matrix environment.
• Prior experience with clinical protocol development and/or regulatory submissions and management.
• Experience working cross-culturally a plus.
• Strong knowledge of clinical operations and the regulatory process, with experience independently running/managing multiple clinical trials preferably within the oncology area.
• EDC including trial management, data review, issuing and resolving queries, CRF design/review/approval.
• Strong interpersonal and communication skills (both spoken and written), with ability to effectively communicate on project planning, progress, tracking etc.
• Strong relationship building skills to work effectively with others in various disciplines and levels.
• Strong leadership and negotiation skills with ability to employ different styles and/or strategies depending on team members and situations.
• Proven ability to manage multiple, complex and competing priorities to effective and efficient conclusion.
• Ability to operate strategically and tactically.
• Sense of urgency and ability to work effectively to timelines.

Clinical Scientist develops study protocols, informed consents, investigator's brochures, and clinical study reports for translational and early clinical development of anti-cancer agents, reviewing trial data to confirm integrity and flag trends. Success in the position means aligning Clinical Operations, the Medical Monitor, study sites, CROs, and vendors so that oncology studies are designed, conducted, and reported in line with ICH/GCP.

Work Activities

• Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
• Collaborate with Clinical Operations to review CRO scope of work, study budget and plans or manuals related to study data, IVRS, central labs etc.
• Interact with internal and external stakeholders (Development Team functions, study sites, vendors, committees, etc.) in support of clinical trial objectives.
• Collaborate together with Clinical Operations and Medical Monitor on design, implementation and conduct of clinical studies in cancer patients.
• Review clinical data to analyze, identify and report trends, confirm the data integrity and prepare interim and final reports of clinical trial data for documents such as CSR, IB, DSUR.
• Contribute to the protocol feasibility assessments, site identification, and vendor evaluation.
• Present data/information to external investigators or study staff (e.g., SIV presentations).
• Review literature to support scientific and medical data analysis and development planning.

Experience & Qualifications

• Minimum of 3-5 years of experience in clinical development, preferably in oncology.
• Experience of successful work in cross-functional project or study team matrix.
• Experience in coordinating collaboration with and training of investigative centers, clinical staff and CROs.
• Comprehensive practical knowledge of the development of study protocols and conduct and reporting of clinical studies in accordance with ICH/GCP and other related regulations or guidelines.
• Awareness of global regulatory and pharmacovigilance environments.
• Excellent data analysis skills.
• Proficiency with all office suite tools (MS Word, Excel, PPT, Project).
• Excellent organizational, project management and time management skills.
• Ability to apply attention to detail, function independently and exercise good judgement.
• Ability to work in a fast-paced, high-growth environment.
• Excellent written and verbal communication skills in English.

The Clinical Scientist guides study design, protocol concepts, and statistical analysis plans across assigned clinical programs, serving as a resource for analyzing and communicating clinical data. Reporting to Clinical Science and Clinical Development leaders and working with investigators, translational sciences, and clinical operations, the Clinical Scientist yields endpoint insight that informs critical program decisions and regulatory filings.

Performance Expectations

• Provide clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
• Provide input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
• Collaborate with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
• Work with study and program teams to achieve program goals and provide deliverables in approved timeframes.
• Apply best regulatory practices and drug development precedent to assigned programs.
• Support the development of regulatory documents for filings and agency meetings.
• Review and interpret scientific knowledge of competitor landscape (molecule/indication).
• Identify issues/problems proactively and recommend solutions.
• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
• Remain up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensure consistent best practice across all activities.

Technical Qualifications

• 1+ years of drug development experience in academia and/or the Biopharmaceutical industry, preferably with experience in the Gastrointestinal, Dermatology or Pain therapeutic areas.
• Knowledge of ICH-GCP, external regulations and procedures required for regulatory filing.
• Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data.
• Very good IT skills with ability to work with large databases.
• Ability to manage priorities and competing demands in a changing work environment.
• Strong oral and written scientific communications skills.
• Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings).
• Ability to strike proper balance between independent work and team interaction, and good team player in a cross functional team.
• Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
• Availability to participate in early or late meetings/teleconferences.

Embedded within Clinical Research, the Clinical Scientist coordinates the preparation and quality control of clinical documents, data presentations, and scientific disclosures such as manuscripts, abstracts, and conference posters. Working closely with senior clinical development staff and multidisciplinary partners in biostatistics, medical affairs, quality assurance, and regulatory, the Clinical Scientist interprets scientific literature to support clinical team decisions and patient-focused programs.

Core Responsibilities

• Represent Clinical Research on cross-functional initiatives and due diligence teams upon management request.
• Interact with cross-functional matrix team personnel and contribute to strategic and scientific planning and execution.
• Read/interpret scientific and medical literature for use in clinical documents and to assist in clinical team decisions.
• Prepare clinical data and clinical program presentations.
• Provide scientific support of scientific data disclosures (manuscripts, abstracts, conference posters).
• Provide quality control support as needed including clinical and regulatory documents and slide decks.
• Represent the company at scientific and industry meetings, as needed.
• Contribute, as required, to protocol development, data review and reconciliation, and essential documents (eg, CSRs, IBs, INDs, publications).
• Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.

Position Requirements

• Knowledge of GCPs, ICH guidelines and FDA regulations, with familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements a plus.
• Understanding of the legal and compliance environment and ability to drive collaboration with the Legal and Compliance team.
• General familiarity with biostatistics, expert in navigating scientific literature, interpretation of data, display of data.
• Highly proficient in standard computer software (Word, Excel, and Power Point), with proficiency in GraphPad desirable.
• Strong interpersonal and written and verbal communication skills, proactive approach, collaborative and flexible in personal interactions at all levels of the company.
• Ability to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and ability to work on multiple projects simultaneously and deal with ambiguity.
• Results driven and able to achieve creative and sound outcomes.
• Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Learning agility and 'scalability' to take on increasing responsibility as the company grows.
• Consistent demonstration and embodiment of company core values Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity.

Reporting to the Senior Medical Director, the Clinical Scientist executes design, safety monitoring, and data analysis work for late-phase clinical trials studying growth hormone therapy. Partnering with cross-functional colleagues and KOLs, the Clinical Scientist evaluates study results and assists in drafting regulatory submissions that optimize product development for the growth hormone team.

Key Responsibilities

• Support clinical trial design, execution, safety monitoring, data analysis and reporting.
• Contribute to critical evaluation and interpretation of study results.
• Assist with drafting and reviewing clinical documents, presentations, and regulatory submissions.
• Complete assigned tasks thoroughly, accurately, and on time.
• Maintain up-to-date knowledge of relevant science, medical information, and regulatory guidance.
• Collaborate with and serve as a clinical research resource for cross-functional colleagues to optimize product development.
• Cultivate relationships with key opinion leaders to represent the interests of the company.

Knowledge Skills & Abilities

• Advanced degree e.g. Ph.D., Pharm.D., Nurse Practitioner, or equivalent.
• Strong track record of scientific and clinical inquiry.
• Understanding of statistical concepts and clinical trial design, and the connection between nonclinical data and clinical data.
• Excellent communication skills (both written and verbal).
• Ability to learn quickly and follow complex directions under pressure.
• Ability to multi-task while remaining organized and attentive to detail.
• Hard-working, trustworthy and collaborative team player.
• Initiative and ability to solve problems of moderate complexity.
• Sound judgement in handling complex, confidential, and regulated information.
• Adherence to rigorous ethical standards.