Clinical Research Physician Job Description

A Clinical Research Physician is the accountable medical lead between a compound's development strategy and the clinical studies that keep its protocols, safety data, and regulatory filings scientifically sound. Pharmaceutical sponsors, biotech companies, and global health programs each need a physician who understands both patient safety and the mechanics of trial design, a distinction that separates this role from site-based principal investigators. Within the organization, the physician sits inside a cross-functional clinical team and is held accountable for the accuracy of clinical study reports and regulatory dossiers that directly affect registration timelines. Regulatory frameworks such as ICH GCP guidelines and IND and marketing authorization requirements set the professional baseline for this work.

As the Clinical Research Physician, you turn a compound's clinical development plan into studies whose safety and efficacy data can withstand health authority review and support new indication approvals. You work as the medical lead within a matrix clinical team of biostatisticians, regulatory affairs, and clinical operations colleagues, typically answering to a Medical Director while guiding peer physicians and scientists.

Career Impact: Authoring clinical study reports and regulatory dossiers gives you a filing and publication record valued across pharmaceutical medicine.

Business Impact: Sound protocol design and timely adverse event review protect trial participants and keep a program's registration timeline intact.

Growth Opportunity: Physicians in this seat commonly move toward Clinical Development Leader or Medical Director roles overseeing entire molecule programs.

Company Value: Sponsors in this space often expect work beyond your primary specialty and support continuing education through conferences and expert engagement.

• Design clinical study protocols in collaboration with biostatisticians and regulatory affairs to meet development plan objectives.
• Own the medical content of clinical development plans for assigned compounds within the therapeutic area.
• Monitor participant safety across ongoing studies, reviewing serious adverse events and emerging safety signals for relationship to treatment.
• Interpret clinical trial data and prepare clinical study reports, regulatory dossiers, and responses to health authority questions.
• Liaise with key opinion leaders and advisory boards to gather scientific feedback on development plans and protocols.
• Support investigator sites as the medical contact for protocol questions, study training, and investigator meetings.
• Review product labeling, publications, and manuscripts emerging from assigned studies for scientific accuracy.
• Guide peer physicians and scientists within the matrix team to achieve study goals and milestones.

• Medical degree (MD or international equivalent) or equivalent work experience, with clinical training in a relevant specialty.
• 2 or more years of clinical research experience in the biopharmaceutical industry, with hands-on clinical study management and conduct.
• Working knowledge of GCP, ICH guidelines, and regulatory requirements governing clinical trials and regulatory filings.
• Proven ability to design clinical trials and interpret results, including study design strengths and weaknesses.
• Medical monitoring experience, including adverse event evaluation and safety data review across studies.
• Ability to lead and influence within a matrix organization spanning multiple functions and external partners.
• Strong oral and written scientific communication skills, including comfortable engagement with external opinion leaders and experts.
• Close attention to detail when working to time-sensitive study milestones and regulatory submission deadlines.

• Board certification or eligibility in a relevant clinical specialty such as internal medicine or infectious diseases.
• Experience in IND filing and authoring protocols and clinical study reports for health authority submissions.
• Record of peer reviewed publications, posters, or abstracts demonstrating scientific contribution in the therapeutic area.
• Therapeutic area experience in infectious diseases, autoimmune disease, or neurology and cardiology trials.

• Protocol amendment count per study, reflecting how sound the original design was.
• Serious adverse event medical review turnaround in days, measuring safety oversight speed.
• Clinical study report delivery against planned dates, in days of variance.
• Health authority query count per submission, reflecting dossier clarity and completeness.
• Site protocol question response time in hours, measuring medical support to investigators.
• Manuscripts submitted per completed study, tracking publication of trial findings.

• Base Salary Range: $250,000 to $350,000 annually, higher at the Medical Director level
• Bonus: Annual target bonus of 15% to 25% of base salary
• Equity: RSUs or stock options, common at both biotech and large pharma
• Health Benefits: Medical, dental, and vision coverage with HSA/FSA and life insurance
• PTO: 20 to 25 days plus company holidays and year-end shutdown
• Common Perks: CME allowance, license and board fees, conference travel, 401(k) match

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

Offers are contingent on a satisfactory background check, which may include verification of medical licensure and drug screening where permitted by law. Candidates must be authorized to work in the United States. 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 during the application process or on the job are available upon request.

The Medical Director, Clinical Research Physician leads medical and scientific strategy for a selected molecular entity, owning clinical development plans and study reports for FDA submissions. Reporting to senior medical leadership, the Medical Director, Clinical Research Physician guides project physicians and a matrix team across regulatory affairs and biostatistics to develop products on time and within cost.

Leadership Responsibilities

• Recruit, supervise, and develop junior medical staff.
• Take responsibility for clinical development plans and own the design of clinical trials and the content of clinical study reports.
• Interpret, report, and prepare results of product research in preparation for worldwide health authority and FDA submissions.
• Take responsibility for medical monitoring/reporting and safety officer activities, and evaluate adverse events (pre and post-marketing) for relationship to treatment.
• Assist Regulatory Affairs in determining requirements for any corrective actions or health authority reporting and in developing drug/device regulatory strategies.
• Act as the medical contact at the company for worldwide health authorities concerning clinical/medical issues.
• Act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees.
• Help explore and evaluate new product ideas to assist in identifying new marketing opportunities.
• Support general Clinical/Medical Affairs activities involving product evaluation, labeling, and surveillance.
• Support early clinical development and discovery activities involving product potential and development for registration.
• Participate on and lead teams for evaluation of new product ideas and implementation of franchise business strategies.
• Take responsibility for assessment of medical publications emerging from the Team and its affiliates.
• Review Company advertising and promotion.
• Manage the budget for all project-related clinical activities.

Education & Experience

• MD (or international equivalent) required.
• Board Certification or Eligibility preferred.
• Experience in Neurology, Stroke, and/or Cardiology trials preferred.
• Significant academic or pre-clinical research experience especially desirable.
• Minimum of 5 years of Drug Development experience and a minimum of 3 years of pharmaceutical industry experience required.
• Phase II/III development or equivalent Academic experience required.
• Experience working in a Matrix environment required.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for appropriate contributions to regulatory filings required.
• Expertise in clinical drug development, including demonstrated ability to develop clinical development plans meeting the highest standards, required.
• Working knowledge of the Microsoft suite of software products, including Excel and Word, required.
• Ability to interface effectively with discovery, preclinical, and marketing is required.

Embedded within a Phase I clinical research unit, the Clinical Research Physician delivers medical oversight of early-phase studies, from protocol and Investigator Brochure review to final screening data review before subjects are authorized for enrollment. Working closely with sponsors, the REC, clinic associates, and physician specialists, the Clinical Research Physician safeguards subject safety and keeps study conduct compliant, supporting reliable study results and sponsor confidence.

Key Responsibilities

• Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study, and provide input to sponsor as indicated.
• Complete FDA 1572 and financial disclosure forms as required and attend study initiation meetings with sponsor.
• Prepare REC submission, review ICF, and communicate with REC during the protocol approval process and on subject safety issues.
• Explain the study to the subject and answer questions, ensure proper consent, and perform a screening physical examination.
• Perform final review of all screening data, ECGs, medical history, and lab work prior to authorization of subjects to be enrolled in the study.
• Assist in the design of study and time/event schedules involving special medical procedures.
• Assist with identifying and maintaining a network of physician specialists to contract on studies.
• Train clinic associates on CPR skills and assessment skills related to reporting adverse events, and facilitate emergency response training and review of clinical safety procedures.
• Present the company's capabilities and experience during sponsor meetings and events.
• Function as a medical/clinical informational resource for the site.
• Assist other departments with development of SOPs, training plans, etc.
• Actively participate in weekly quality review of study results.

Required Qualifications

• MB degree.
• Diploma in Human Pharmacology, Completion of Specialty Training in Clinical Pharmacology, and higher degrees in pharmacology.
• Relevant postgraduate qualification or willingness to pursue further education in pharmaceutical medicine or human pharmacology.
• Advanced Life Support certification (training provided for new employees) with re-certification required every 4 years.
• Board certified or board eligible in a primary care specialty, i.e., family practice, internal medicine, A&E medicine.
• 4+ years of clinical medical experience for full PI responsibilities, including a minimum of 2 years' experience in a Phase I unit.
• Minimum of 2 years' experience as a PI in a Phase I unit.
• Previous clinical research experience preferred.
• Ability to work a flexible schedule.

Reporting to global health clinical leadership, the Clinical Research Physician, Global Health shapes First-in-Human and Proof of Concept studies and may serve as Clinical Sciences Leader for specific studies. Partnering with peer Medics, scientists, and external partners ensures the unit meets its goals and milestones in infectious diseases affecting low-resource settings.

Core Functions

• Take on additional responsibility as the Clinical Sciences Leader (CSL) for specific studies where appropriate.
• Be considered for Clinical Development Leader (CDL) and/or Early Development Leader (EDL) roles if appropriate.
• Support the business development team in reviewing licensing/partnering opportunities as required.
• Deliver presentations within and external to the company.
• Develop and maintain a high level of current knowledge in the therapeutic area.
• Serve as an active matrix team member by providing guidance and direction to peer Medics and scientists to ensure the successful achievement of the unit's goals and milestones.
• Actively participate in the development of others within the organisation and provide guidance.

Skills & Qualifications

• Experience in the design and conduct of First-in-Human and Proof of Concept Studies, and medical monitoring experience across a range of studies.
• Experience in Infectious Diseases, particularly diseases disproportionately impacting patients in low-resource settings.
• Record of publications (peer-reviewed journals, posters, and abstracts) and track record of managing collaborations with external stakeholders.
• Good appreciation of the drug development process for adult and pediatric indications and knowledge of clinical trial conduct.
• Ability to interpret clinical trial results, including the strengths and weaknesses of study design and application of study results to clinical practice.
• Ability to learn new aspects of the therapeutic area through reading, conference attendance, and engagement with experts, with commitment to continuing education.
• Ability to operate effectively across functions and geographic interfaces and to influence and lead in a matrix organization, including external partners.
• Flexible, focused, enthusiastic, able to identify opportunities, able to operate in a complex organizational environment, and willing to challenge the status quo.
• Comfortable being personally accountable, capable of arguing own case in the best interest of patients, visible, and with an open style of interaction.
• Strong oral and written communication skills and comfortable engaging and communicating with external opinion leaders.

Sitting at the intersection of patient care and clinical research, the Clinical Research Physician leads a team of researchers and clinical staff through Phase 2 and 3 trials, evaluating volunteer eligibility and reviewing diagnostic reports. Operating across Regulatory Affairs, Clinical Operations, and Patient Engagement, the Clinical Research Physician executes research protocols to FDA regulations and GCP guidelines, protecting participant safety and supporting biopharmaceutical sponsors.

Primary Duties

• Provide clinical expertise in the conduct of clinical trials.
• Build positive relationships and networks with internal and external medical professionals and local opinion leaders.
• Work closely with colleagues in other functions, including Regulatory Affairs, Clinical Operations, and Patient Engagement.
• Lead and provide oversight to a team of researchers and clinical staff involved in the conduct of clinical trials.
• Take responsibility for successful execution of research protocols according to FDA regulations and GCP guidelines.
• Evaluate study volunteers' eligibility for clinical trials.
• Perform physical exams and assessments as required per research protocols.
• Complete all industry-required training.
• Assess study patient health through interviews and physical examinations.
• Communicate information to patients regarding diagnosis and treatment goals.
• Review all diagnostic reports and provide clinical direction to the study team.

Qualifications & Experience

• Board certification in Family Practice or Internal Medicine.
• Current license to practice medicine in the state with no history of license suspension or debarment.
• 10 years' post-training experience as a physician.
• Previous clinical research experience (at least 2 years).
• Advanced knowledge of treatment and drug interactions.
• Ability to build rapport with patients and biopharmaceutical sponsors.
• Strong attention to detail.
• Strong leadership qualities.
• Excellent communication skills.

A key member of the clinical trial site team, the Clinical Research Physician owns participant wellbeing across studies, acting as principal investigator or co-investigator once trained and checking inclusion/exclusion for eligible recruitment. Collaborating across sponsors, clients, and site colleagues, the Clinical Research Physician ensures ICH/GCP compliance and appropriate adverse event reporting that keep trials safe and credible.

Duties

• Act as principal investigator (PI) or co-investigator once trained, ensuring ICH/GCP and local regulations are met.
• Conduct clinical trials in line with the protocol and ensure the recruitment of eligible participants onto the studies.
• Review screening, pre-screening, and screening success rates for clinical trials.
• Provide information and support to consenting participants for a clinical study and take responsibility for checking patient inclusion/exclusion to studies.
• Liaise with and develop positive relations with sponsors, clients, and clients' contractors as required, projecting a helpful and courteous company image.
• Carry out clinical evaluation and clinical investigation of participants.
• Constantly seek and suggest quality improvements.
• Take responsibility for ensuring serious adverse events/adverse events are reported appropriately.
• Take responsibility for the medical wellbeing of participants during the clinical trial and refer to specialists or GP as required.

Requirements

• Registered doctor with no limitations to practise.
• Ideally some previous experience within clinical research.
• Working knowledge of GCP (ICH/GCP and local regulations compliance).
• Meticulous attention to detail in recording patient information and data, ensuring any queries are acted upon in a timely and efficient manner.
• Inclination to provide practical help and guidance to colleagues, providing practical solutions for any problems and supporting their development.
• Team player, capable of building and sustaining positive relationships with colleagues as well as patients.

Successful local registration of new infectious disease compounds depends on the Clinical Research Physician, who shapes clinical study design and constructs high-quality protocols as project physician at all stages of clinical development. Serving as the contact for site study teams, the Clinical Research Physician works with biostatisticians, regulatory affairs, clinical operations, and external scientific leaders to ensure safety, data quality, and sound regulatory dossiers.

Accountabilities

• Work collaboratively with the clinical project team on all scientific aspects of designing and planning trials.
• Work closely with the regulatory affairs, project management, clinical trial operations, and commercial teams for the planning and execution of local registration studies.
• Compile required documents of clinical data and plans in support of local registration.
• Lead clinical study design and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct high-quality clinical study protocols.
• Engage and introduce new compounds in development to external scientific leaders (KOLs) and seek feedback on the clinical development plan and protocols as needed.
• Work with the clinical operations team in planning and executing site assessment, selection, and training of investigators and staff.
• Perform clinical monitoring for studies and work with the study team to ensure safety/efficacy/quality, accurate data capture, and review of serious adverse events.
• Serve as the contact for the site study team to address protocol-related questions and emerging safety issues.
• Provide input on and approve monitoring plans/reports/data listings.
• Interpret and prepare clinical study reports, regulatory dossiers, and regulatory responses, and review product labels related to assigned compounds.
• Participate in the preparation and review of manuscripts for publication.
• Participate in due diligence evaluation, identify gaps/opportunities in health care, and contribute to conceptualizing plans/studies to address the emerging opportunities.

Experience & Qualifications

• Medical Degree (MD) or equivalent, with clinical training in infectious diseases or internal medicine highly valued.
• 5+ years of relevant industry experience, preferably with ID specialization or relevant work.
• Proven track record of accomplishment in the field of clinical development, with the relevant knowledge, experience, and skills.
• IND filing experience is highly desirable.
• Previous experience in protocol and study report writing is highly desirable.
• Experience and capability to maintain professional relationships with therapeutic area opinion leaders to discuss the science and research approaches critical for study protocol design and data interpretation.
• Advanced working knowledge of good clinical practice and International Conference on Harmonization Guidelines required.
• Understanding of cross-functional processes involved in study design and execution, including protocol development, data management, safety/pharmacovigilance, biostatistics, medical writing, quality assurance, and regulatory and medical affairs.
• Excellent interpersonal skills with a proven ability to work highly effectively with multiple departments.
• Attention to detail in a time-sensitive environment.
• Flexibility to work in a rapidly growing matrixed environment and outside the area of primary medical specialization.
• Excellent language skills in both English and Chinese, fluent in verbal and written communication.

As the Sub-Investigator/Clinical Research Physician, this role leads trial site supervision for neurological studies such as Alzheimer's and ADHD research, delegating site tasks and ensuring accurate medical records and study documentation. The research team relies on this work to follow set protocols and specific regulations, keeping every study compliant and its data dependable.

Role Responsibilities

• Supervise the trial site and delegate all tasks associated with it.
• Oversee all team members and ensure they perform their duties according to set protocols.
• Ensure that all tools compatible with the requirements of the study protocol are accessible to everyone.
• Follow specific regulations whilst conducting the studies.
• Ensure all medical records/study documentation is accurate.

Position Requirements

• Medical Doctor, GMC registered.
• MRCP or similar membership exams.
• Clinical research experience.
• Exposure to clinical research phases 0 to 4 is highly desirable.
• Great understanding of neurological research sectors such as Alzheimer's and ADHD.
• Great management and leadership skills.
• Fast-paced and dynamic individual.

Clinical Research Physician builds a locally tailored development strategy within the therapeutic area, leading the molecule development plan end to end and serving as medical monitor through site visits, data review, and regulatory filings preparation. The work directly supports new indication approval, drawing on consultation with KOLs, Medical Advisory Boards, and local health authorities to turn strategy into an execution plan.

Areas of Ownership

• Provide disease expertise to the therapeutic area and work out a locally tailored development strategy from end to end.
• Lead and drive the molecule development plan and transform strategy into an execution plan.
• Provide clinical/scientific input and support as medical monitor in trials, such as site visits, training CRAs on study design, acting as speaker in investigator meetings, supporting ethics approvals, data review, regulatory filings preparation, and supporting inspections from the local side.
• Assess and drive new indication approval.
• Author clinical documents of local data for CTN and MAA filing and publication, interpret clinical trial data, and participate in local health authority interaction.
• Lead peer-to-peer discussions in consultation with KOLs/Medical Advisory Boards Meetings/Expert Panels.

Knowledge Skills & Abilities

• Medical Doctor preferred but not limited.
• 2+ years of clinical practice experience, with autoimmune disease/ophthalmology preferred but not limited.
• 2+ years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical), with experience in autoimmune disease/ophthalmology preferred.
• Experience with clinical study management and conduct.
• Experience with scientific expert interactions.
• Knowledge of Good Clinical Practice (GCP), FDA, EMEA/CHMP, and NMPA regulations and guidelines, and applicable international regulatory requirements.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
• Fluency in English, both oral and written communication.