ASSOCIATE SCIENTIFIC DIRECTOR JOB DESCRIPTION

Understanding why a drug candidate succeeds or fails in humans takes more than data. It takes someone who can translate pharmacometric models, preclinical toxicology findings, and exposure-response analyses into decisions that move a program forward or stop it from advancing. That person is the Associate Scientific Director. Sitting between laboratory science and regulatory strategy in a drug development organization, this role owns the scientific rationale behind IND filings, safety assessments, and clinical dose predictions. No other title in the development hierarchy is accountable for both the mechanistic data generation and the regulatory interpretation it produces.

As the Associate Scientific Director, you own the scientific strategy and execution for one or more drug development programs spanning preclinical safety, pharmacology, or translational research, directly influencing go/no-go decisions that determine whether a candidate reaches human dosing. You work within a cross-functional development team - typically reporting to a Senior Director or Director - and serve as the primary scientific authority in regulatory submissions, safety review teams, and cross-functional program meetings.

Career Impact: Authoring IND and BLA sections and presenting findings to FDA review teams establishes a regulatory track record that is highly portable across the pharmaceutical and biotech sectors.

Business Impact: The mechanistic analyses and safety characterizations this role produces determine whether development candidates advance to first-in-human studies, protecting both patients and organizational investment.

Growth Opportunity: The scope of the role - spanning preclinical data, regulatory strategy, and cross-functional leadership - creates a well-documented path toward Senior Scientific Director and VP-level positions within drug development organizations.

• Design and execute mechanistic studies, population PK/PD analyses, or safety characterization programs to support candidate drug development decisions.
• Lead the authoring and scientific review of IND, BLA, and CTA sections, serving as subject matter expert in agency interactions.
• Direct cross-functional issue resolution teams by interpreting preclinical and clinical findings and communicating recommended development actions.
• Evaluate and implement novel in vitro, in vivo, or quantitative modeling approaches to strengthen the scientific foundation of assigned programs.
• Mentor junior scientists and manage scientific staff performance, goal-setting, and career development within the team.
• Partner with Regulatory Affairs, Clinical Pharmacology, Toxicology, and Biomarker functions to align scientific strategy across program milestones.
• Monitor the emerging scientific literature and competitive landscape to identify methodological advances applicable to assigned programs.
• Author abstracts, manuscripts, and posters for external scientific publication to maintain and build domain credibility.

• PhD in a life science discipline - including pharmacology, toxicology, pharmaceutics, or a related biomedical field - or equivalent work experience.
• 5 or more years of drug development experience in a pharmaceutical or biotech setting, with direct accountability for preclinical or translational program deliverables.
• Demonstrated expertise in at least one core scientific domain relevant to drug development: pharmacometrics, investigative toxicology, translational PK/PD, analytical sciences, or medical affairs.
• Experience authoring or contributing to regulatory submissions including INDs, CTAs, NDAs, or BLAs, with knowledge of FDA and ICH guidelines governing those documents.
• Track record of leading or contributing to cross-functional development teams, including direct or matrix management of scientific staff.
• Proven ability to design studies, interpret complex datasets, and translate findings into clear recommendations for program decision-making.
• Strong scientific writing skills with a record of peer-reviewed publications, regulatory documents, or scientific conference presentations.
• Demonstrated ability to manage multiple programs or workstreams concurrently while meeting regulatory and internal milestone timelines.

• Board certification or postdoctoral training in a specialized discipline such as toxicology, comparative pathology, or clinical pharmacology.
• Experience with GLP study oversight, including design, CRO management, and peer review of study reports.
• Publication record in pharmacometrics, translational pharmacology, or a relevant biomedical specialty, reflecting active scientific engagement beyond internal deliverables.
• Familiarity with global regulatory requirements beyond the US, including EMA guidance on quantitative analysis and risk management plan submissions.

• Regulatory submission acceptance rate, reflecting scientific rigor of IND and BLA sections authored or reviewed.
• Number of program go/no-go decisions supported with complete mechanistic data packages within agreed timelines.
• Time from preclinical data lock to IND-ready regulatory document, measuring throughput of the scientific writing function.
• Peer-reviewed publications and conference abstracts per year, reflecting external scientific contribution and domain visibility.
• Staff development milestones achieved for direct or indirect reports, including goal completion and retention rate within the scientific team.
• Typical tools: pharmacometrics and modeling platforms (commonly NONMEM, Monolix, or Phoenix); statistical computing environments (commonly R or SAS).

• Base Salary Range: $165,000 to $220,000 annually, depending on seniority and domain specialization.
• Bonus: Annual performance bonus typically 15% to 25% of base salary.
• Equity: Stock options or RSUs common in biotech; less standard in large pharma.
• Health Benefits: Medical, dental, and vision coverage, typically effective from first day of employment.
• PTO: 15 to 25 days annually, plus company holidays; some employers offer unlimited PTO.
• Common Perks: Conference travel and publication support, tuition reimbursement, 401(k) with employer match, and lab or home-office stipends for remote-eligible roles.

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

Drug development employers using this template are committed to maintaining workplaces free from discrimination. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Candidates requiring reasonable accommodations during any stage of the hiring process should notify the recruiting team. A background check, which may include employment history and credential verification, is required as a condition of employment. All candidates must be authorized to work in the United States.

The Associate Scientific Director owns strategic editorial development and publication plan management for client communication programs at IPP level, serving as the primary editorial contact across large-scale accounts. The role shapes the quality of educational materials across medical writing, production, and approval workflows, directly enabling clients to meet their scientific and marketing objectives.

Key Responsibilities

• Develop and implement strategic communication plans in collaboration with client and internal account teams; act as the primary editorial contact for the account team on large programs.
• Design, develop, implement, and manage publication plans.
• Research, write, edit, and proof copy to the highest standard for a full range of educational materials and target audiences.
• Manage and co-ordinate materials through internal, client, and speaker approval, creative, design, and production to print, according to internal procedures.
• Check proofs and printer's proofs (text, layout, color, specification) and sign off for print and production; implement client and author corrections accurately and precisely.
• Mentor Medical Writers and assist in training of Associate Medical Writers; develop Editors, Editorial Assistants, and Editorial Secretaries.
• Provide on-site support including writing, editing, video interviewing, faculty support, competitor intelligence gathering, and moderating meetings.
• Make presentations to clients, speakers, and third-party organizations; provide medical expertise and consultancy in areas of main strength, internally and externally.
• Establish, develop, and maintain opinion leader relationships; work with Editorial Unit Manager and Executive Editorial Manager to plan resource to match program needs.
• Utilize and manage freelance assistance through commissioning and briefing; proactively develop new business and assist New Business Department with pitches and presentations.
• Perform quality control checking of copy of other Medical Writers across the department.

Required Qualifications

• Advanced life science (PhD, PharmD, MS) or medical (MD, DO) degree.
• 3+ years of medical or scientific writing and editing experience in a communications agency environment, including experience of good multidisciplinary teamwork.
• Good knowledge of therapeutic areas, therapies, and the pharmaceutical industry; familiarity with code of practice guidelines for medical copy and copyright issues; familiarity with drug development regulatory guidelines.
• Excellent scientific writing ability with skills to adapt for different target audiences and meet client strategic marketing objectives; attention to detail in style, consistency, grammar, syntax, scientific accuracy, proofreading, and layout.
• Good knowledge of print and production procedures; understanding of media including print, video, and new media.
• IT skills including word processing, database searching, graphics packages, and internet tools.
• Excellent project management, organizational, and problem-solving skills.
• Excellent interpersonal and communication skills with ability to lead a small project team; presentation, interview, and appraisal skills.

Embedded within a cross-functional multidisciplinary organization, the Associate Scientific Director of Pharmacometrics leads the transformation of non-clinical and clinical data into model-informed analyses that drive dose selection, trial design, and drug development decisions. Working closely with internal teams and external collaborators, the role delivers population PK, PK/PD, and disease progression analyses that advance innovative drugs to patients.

Core Functions

• Apply state-of-the-art quantitative clinical pharmacology and pharmacometric methods to yield high-value support for critical development decisions.
• Develop and execute M&S plans to support candidate drug development.
• Independently develop and report population PK, PK/PD, and disease progression analyses.
• Proactively incorporate and develop approaches based on review of relevant scientific literature.
• Perform meta-analysis using proprietary and literature data.
• Apply FDA and ICH guidelines in the design of clinical studies and drug development strategy.
• Author M&S sections for regulatory interactions and responses.
• Participate in maintaining scientific awareness and presence through preparation of abstracts and manuscripts for publication.
• Evaluate and incorporate new M&S tools and initiate trainings to strengthen pharmacometric capabilities on a continuous basis.
• Actively contribute to a high-growth, transformational company culture built on bold, relentless, curious, and collaborative values.

Qualifications & Experience

• PhD or PharmD with a focus in pharmacokinetics, pharmacology, pharmaceutics, or a related field with 5–10 years of drug development experience.
• Track record of regulatory filings (NDA/BLA) and knowledge of global regulatory requirements and guidance on quantitative analysis.
• Deep understanding of pharmacometric principles and M&S strategies, including binary and categorical data analyses, time-to-event models, Poisson models, logistic regression, MCMC, and Bayesian methods as applied to exposure-response analyses, meta-analyses, and population PK/PKPD analysis.
• Hands-on proficiency in pharmacometrics tools including NONMEM, R, Julia, Monolix, and Phoenix.
• Strong publication record in pharmacometrics.
• Excellent interpersonal, verbal, and written communication skills with ability to function in a highly matrixed team environment.
• Curious, collaborative, and relentless in pursuing successful outcomes when working with multifunctional teams.

Reporting to senior management, the Associate Scientific Director, Hematology Oncology directs, plans, and manages development scientists across feasibility studies, new product development, and manufacturing transfer. Partnering with QA/RA, QC, Manufacturing, and Marketing functions, the role ensures scientific integrity and regulatory compliance across all phases of the product development lifecycle.

Primary Duties

• Provide expert advice to management and technical personnel regarding development technologies and activities.
• Lead and support product development projects across all phases of the product development process.
• Plan and manage new product development projects in alignment with company priorities and senior management direction.
• Evaluate new technologies for possible use in product development and contribute ideas for new products.
• Provide technical input and guidance to project teams and technical staff; review and approve Development Reports.
• Participate in developing and implementing improved standards for new product development and adherence to the Design Control Process.
• Supervise direct reports including interviewing, hiring, training, goal setting, performance evaluation, and career development.
• Present or support staff in presenting technologies at scientific and customer or partner meetings.
• Ensure staff are trained in and follow company safety requirements; perform occasional bench work as required.

Skills & Qualifications

• PhD in a scientific field or equivalent combination of education and experience required; bioinformatic skills preferred.
• At least 10 years of work experience, with at least 4 years in a senior technical role related to product development.
• Experience working with multiple functions including QA/RA, QC, Manufacturing, Marketing, and Business Development.
• Knowledge of QSR, ISO, and CE-IVD requirements with experience on teams that have successfully launched products.
• Proven problem-solving and follow-up skills with ability to develop appropriate resolutions to improve deliverables.
• Strong organizational and prioritization skills.
• Demonstrated ability to influence and create change.

Sitting at the intersection of preclinical pathology and regulatory strategy, the Associate Scientific Director of Pathology supports the characterization of adverse effects of modified mRNAs and delivery systems in preclinical species, reporting to the Sr. Director of Pathology. Operating across molecular pathology, investigative toxicology, and IND-enabling activities, the role advances safer delivery systems and establishes the regulatory position required for clinical trials.

Duties

• Develop and execute pathology sciences laboratory practices to support platform and cross-functional needs including molecular pathology, histology, and investigative pathology and toxicology.
• Support the establishment of state-of-the-art processes for evaluating and characterizing the effects of modified mRNAs in preclinical species.
• Interface with drug metabolism and pharmacokinetic experts to characterize the full pharmaco- and toxicodynamic properties of this novel class of agents.
• Participate in developing Moderna's pathology assessment scheme for potential clinical candidates, including peer review of GLP and regulatory enabling studies.
• Prepare appropriate sections of regulatory documents to support the filing of IND, CTA, and other applications for human dosing.

Requirements

• DVM with or without PhD in comparative pathology (ACVP board certification preferred), pharmacology, and/or toxicology with 5+ years overseeing Safety Assessment activities in pharmaceutical development; experience with nucleic acid-based and nanoparticle tox/path strongly preferred.
• Significant contributions to the success of novel pharmaceutical agents with direct experience authoring study reports and regulatory documents supporting applications for human dosing.
• Experience conducting outsourced GLP toxicology studies and interfacing with scientific tox/path staff at leading CROs.
• Strong expertise in one or more of the following: immunology, nanoparticle biology and pathology, or the complement system.
• Strong investigative toxicologic and pathology skills to interpret chemical-based toxicity and morphological and clinical pathology changes related to chemical exposures.
• Significant experience interpreting clinical pathology data from preclinical studies.
• Strong skills in teamwork, communication, detail orientation, independence, results orientation, multi-tasking, and sense of urgency.

A key member of the Cellular & Molecular Toxicology team within Predictive, Investigative, & Translational Toxicology, the Associate Scientific Director leads investigative toxicity studies through the design and supervision of scientific and technical activities. Collaborating across PITT and CMT leadership globally, the role builds mechanistic understanding of toxicity issues during drug development and delivers findings that resolve target liability and nonclinical safety questions.

Functions

• Serve as Subject Matter Expert and represent PITT on issue resolution teams.
• Supervise and mentor scientific staff.
• Design and conduct experiments and develop fit-for-purpose assays for screening and mechanistic toxicity evaluations in response to target liability assessments and nonclinical or clinical findings.
• Evaluate and implement novel in vitro toxicology models and assays.
• Maintain cellular and molecular toxicology expertise through collaborations, organizational associations, literature reviews, continuing education, and publications.
• Partner with Global Lead of CMT to establish strategic goals and objectives.
• Identify topics for internal and external scientific publication and author publications, posters, and documents for official communication.

Experience & Qualifications

• PhD in Toxicology or a related field with 2–5 years of postdoctoral training and 6+ years of relevant work experience.
• Board Certification in Toxicology preferred.
• Experience designing and conducting mechanistic investigative studies using cell-based models required.
• Experience with organotypic models, drug modalities beyond small molecules, and multi-disciplinary teams preferred.
• Experience leading people and projects preferred.
• Advanced knowledge of cellular and molecular toxicology required.
• Track record of working collaboratively to solve sophisticated scientific problems required.
• Highly motivated, curious, and organized with a team-oriented mentality; ability to thrive in a fast-paced, dynamic environment.
• Excellent written, visual, and oral communication skills.

Building a high-performing analytics team across therapeutic areas depends on the Associate Scientific Director, Molecular Property Analytics, who leads molecule property analytics within Drug Discovery Data Sciences. Based within an organization with R&D sites in Belgium and across the US, the role evaluates new technologies, fosters scientific publication, and enables data-driven discovery decisions that strengthen the company's drug development pipeline.

Accountabilities

• Manage the activities of the molecule property analytics team across therapeutic areas, projects, and capabilities build-up.
• Drive a culture of innovation, attract talent, and grow industry-leading expertise.
• Foster a team environment built on trust and collegiality.
• Communicate effectively and develop the abilities of others to do so.
• Evaluate and make recommendations regarding the acquisition or building of new technologies, including performing due diligence on potential partnering and M&A opportunities.
• Provide scientific leadership and impact within the company and beyond.
• Encourage the team to publish in peer-reviewed journals and present at scientific meetings.

Education & Experience

• PhD in data science with deep exposure to a discovery-relevant field, or PhD in a discovery-relevant field with Master's-level training in data science and deep exposure to advanced frameworks and solutions, or an equivalent trajectory.
• Multiple years of experience working in multidisciplinary teams, preferably in an industrial or semi-industrial setting, including experience in leadership and mentorship roles.
• Passion for and track record of planning and delivering complex projects with a robust scientific foundation.
• Deep and frequent exposure to advanced machine learning frameworks and solutions.
• Self-motivated, proactive, and enthusiastic team and bridge builder who encourages confidence and dedication.

As the Associate Scientific Director / Scientific Director, CME, this role leads needs assessment development and high-quality scientific content creation for grant proposals and CME/CE accreditation programs within a continuing medical education company. The CME team relies on this work to produce peer-reviewed articles, monographs, slide decks, and other educational materials that meet AMA and OIG standards for faculty and healthcare audiences.

Operational Focus

• Develop and write needs assessments for grant proposals.
• Develop, review, and edit high-quality scientific content including peer-reviewed articles, monographs, manuscripts, slide decks, case studies, video programs, and other CME/CE materials.
• Perform literature review of clinical trials, peer-reviewed articles, and other data sources to obtain validated content for needs assessments and grant request recommendations.
• Manage and mentor junior team members as applicable.
• Work closely with faculty thought leaders to develop educational content.
• Collaborate with internal staff and teams to ensure timely delivery of high-quality content.

Technical Qualifications

• MS, PhD, MD, PharmD, or DO advanced degree.
• Approximately 2 or more years of experience within a Continuing Medical Education company.
• Needs assessment writing and development experience.
• Understanding of AMA and OIG guidelines.
• Microsoft Office proficiency.
• Excellent time management and multitasking skills with ability to deliver projects on time.
• Strong written and verbal communication and presentation skills.
• Ability to work both independently and as a team member.

Associate Scientific Director, Publications & Medical Affairs leads publication planning and tactical execution across posters, abstracts, manuscripts, and live event materials within a medical communications agency. The work directly supports the development of writers and editors and advances the company's medical affairs capabilities through a remote-first model with periodic congress travel.

Key Deliverables

• Develop posters, abstracts, manuscripts, slide decks, training modules, and materials for live events.
• Mentor and develop writers and editors.
• Oversee publications planning and tactical execution, working hands-on initially.
• Work remotely with periodic travel throughout the year for congresses and related events.
• Pursue ongoing growth and career advancement within a clear internal pipeline.
• Maintain work-life balance to support sustainable, long-term engagement with the company.

Position Requirements

• Advanced degree (PhD, PharmD, or MD preferred).
• 1+ years of experience in a medical communications or advertising agency.
• Experience in publications and/or medical affairs; experience with direct reports and mentorship.
• Traditional medical writing background strongly preferred with strong knowledge of GPP guidelines.
• Strong communications skills with ability to work both independently and in a collaborative, team-oriented environment.
• A desire to learn, grow, and contribute meaningfully through the work; willingness to travel multiple times per year.

The Associate Scientific Director, Pharmacovigilance & Risk Management produces safety evaluations, signal detection analyses, and key regulatory documents including DSURs, RMPs, and PBRERs for major ViiV products across clinical development and post-marketing settings. The role advances compliance and patient safety by providing proactive clinical safety input to Safety Review Teams and cross-functional matrix teams at every stage of the product lifecycle.

Strategic Responsibilities

• Lead pharmacovigilance and risk management planning for designated products and contribute to benefit-risk assessments and Risk Management Plans in partnership with the product safety physician; ensure risk-mitigation strategies are implemented in clinical study protocols and/or product labelling.
• Facilitate and chair Safety Review Teams, provide data for review, and actively contribute to interpretation and discussion; provide input on cross-functional teams addressing urgent safety issues.
• Represent SERM on Clinical Matrix Teams and Project Teams for development compounds; provide clinical safety input into Clinical Development planning activities in partnership with the product safety physician.
• Review and provide technical approval for investigator brochures, protocols, informed consents, final study reports, and external data monitoring committee charters.
• Conduct routine signal detection activities including aggregate data review, disproportionality analysis, literature review, and individual case safety report review; communicate, escalate, and document outcomes; proactively propose review priorities with the product safety physician and ViiV's Head of Safety & Pharmacovigilance.
• Lead data evaluation, present findings to the SRT and key stakeholders, and produce regulatory supporting documentation for labelling updates.
• Author periodic regulatory documents (PBRERs, DSURs) and support local operating companies with license renewal documentation; contribute to Safety sections for global regulatory submissions for new products, formulations, or indications.
• Monitor safety issues related to product defects or manufacturing and communicate with appropriate stakeholders.

Knowledge Skills & Abilities

Bachelor's or above degree in a biomedical or health care-related speciality.

• Knowledge of relevant pharmacovigilance regulations and methodologies.
• In-depth understanding of causality assessment, safety signal evaluation, and proactive risk management strategies including labelling changes and safety monitoring.
• Knowledge of statistics, pharmacoepidemiology, drug utilization, and the drug development and approval process in major countries.
• Advanced evaluation and analytical thinking skills for scientific literature review, data gathering, synthesis, analysis, and interpretation.
• Strong medical and scientific writing skills; sound computing skills.
• Highly effective communication skills with excellent negotiating, influencing, and persuasion skills.
• Strong matrix leadership skills with ability to train, coach, and mentor others.
• Able to manage and coordinate tasks and projects across multiple deadlines with attention to detail.
• Demonstrates initiative, creativity, resilience, and the ability to deal with ambiguity and shifting priorities
• Proactively contributes ideas to improve existing operations.

Embedded within the Analytical Sciences group and reporting to the Director of Analytical Sciences, the Associate Scientific Director, Mass Spectrometry oversees a staff of eight and provides technical, managerial, and strategic leadership for the core MS function. Working closely with Analytical Development, Bioprocess, Pharmaceutical Sciences, and Data Sciences, the role advances CMC analytical strategies and supports regulatory filings from IND to BLA for biologics products worldwide.

Ownership Areas

• Lead the core mass spectrometry group, providing technical, managerial, and strategic leadership.
• Mentor MS core group members on intra- and inter-departmental interactions to facilitate first-in-human and late-phase drug development and biologics registration.
• Identify key strategic areas of technology development to position the MS core group to meet internal demand in a scalable manner.
• Review MS data and technical reports associated with regulatory filings and interdepartmental process development activities.
• Manage MS core group meetings to establish a common vision, build team inclusivity, mentor junior staff, and facilitate group review and discussion of MS data.
• Oversee relevant CMC sections of regulatory submissions and serve as subject matter expert in regulatory interactions.
• Drive implementation of new MS technologies to support company business objectives.
• Collaborate with Analytical Development, Bioprocess, Pharmaceutical Sciences, and Data Sciences to advance understanding of process-to-product quality relationships.
• Cultivate and maintain external presence through collaborations to advance industry practices in drug development, manufacturing, and regulatory strategy.
• Guide career development of MS core group staff and build leadership capability within the group.

Professional Experience

• PhD in Biological Sciences or equivalent with a minimum of 8 years of relevant industrial experience, or BS/MS with a minimum of 17 years of relevant experience.
• Prior experience managing and guiding the careers of scientific staff; experience authoring relevant CMC sections of regulatory submissions (IND/IMPD and BLA).
• SME-level expertise in the use of mass spectrometry for biotherapeutic protein characterization in R&D.
• Deep understanding of MS characterization activities supporting late-stage programs through product characterization and registration.
• Extensive experience with common MS instrument platforms and MS data analysis software.
• Strong analytical skills with ability to distill key information from various data sources.
• Demonstrated ability to link molecular product quality attributes to analytical assays for product quality release and stability, and to process optimization across cell-line development, cell culture, purification, and conjugation.
• Demonstrated ability to collaborate and lead cross-functional technical teams.
• Excellent written and oral communication skills; ability to solve problems methodically and act independently.

Reporting to the Director and Disease Lead, the Associate Scientific Director, US Medical Affairs develops and executes Medical Affairs strategy for lymphoma/CLL assets across clinical development stages, serving as the headquarters-based therapeutic area expert. Partnering with Scientific Communications, global affiliates, and cross-functional teams, the role enables publication strategy, investigator-initiated trial support, and scientific engagement with external experts and key stakeholders.

Role Responsibilities

• Collaborate with Medical Affairs colleagues to guide and execute therapeutic area strategy and tactics with appropriate use of resources.
• Assist the Director and Disease Lead as a therapeutic area expert in internal and external venues including Medical Affairs sub-teams and advisory boards and steering committees.
• Support Medical Affairs cross-functional working groups and represent BMS at professional meetings, congresses, and local symposia.
• Support the planning and execution of Medical Affairs Sponsored Trials and registries within standards for compliance, quality, timeliness, and budget.
• Provide scientific and clinical input and review of disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, webcasts, IIT protocols, Commercial Brand plans, and grant requests.
• Track priority Medical Affairs tactics and performance to goals and budget.
• Partner with Scientific Communications on publication strategy, data gap analysis, and key messages.
• Assist with scientific searches, data summaries, and preparation for site visits, corporate visits, and payor presentations with key stakeholders; travel as required (approximately 15%).

Background & Experience

• Advanced degree (MS, PhD, or MD) in medicine, molecular biology, genomics, cancer biology, or other relevant life sciences area preferred.
• 5-10 years of industry experience in clinical/translational research and/or medical affairs in hematology or oncology.
• Master's degree holders with 5+ years of relevant industry experience may also apply; experience in the conduct of clinical trials in hematology/oncology preferred.
• Knowledge and application of data sources, reports, and tools for solid plan creation.
• Excellent analytical skills and solid experience translating medical and clinical information into medical affairs strategies; proficiency in scientific and clinical data review and interpretation.
• Experience with database mining and bioinformatics skills a strong plus.
• Experience creating and managing budgets.
• Excellent oral and written communication skills including large group presentations, interactive facilitation, and 1:1 discussions with thought leaders.
• Matrix leadership of cross-functional teams with strong organizational skills; demonstrated customer focus and credibility.

Sitting at the intersection of molecular immunology and preclinical drug development, the Associate Scientific Director, GI Drug Discovery leads independent design and implementation of discovery pipeline programs for immune-mediated GI diseases including celiac, reporting to the Senior Director, Celiac Discovery within the GI Drug Discovery Unit. Operating across chemistry, DMPK, safety, translational, and clinical development functions, the role advances go/no-go decisions that build the company's external scientific reputation through publication and regulatory submissions.

Job Functions

• Provide scientific contributions with significant impact on portfolio progress or development of technical capabilities benchmarked to industry best-in-class.
• Contribute to development and implementation of scientific strategy through tangible deliverables; challenge dogmas and actively pressure-test ideas cross-functionally and via external network.
• Validate, nominate, and progress drug discovery pipeline programs through direct project champion roles and management of junior staff.
• Evaluate, establish, and integrate external programs from academic or BD collaborations into the GI/Inflammation pipeline following established strategic focus areas.
• Matrix with chemistry, DMPK, safety, translational, biomarker, and clinical development functions to advance pipeline programs.
• Provide significant input into department strategy including areas of scientific focus, partnerships, and collaborations.
• Participate in resourcing and budget planning for pipeline programs.
• Contribute to the preparation, editing, and review of documents for regulatory submission including study reports, IBs, and INDs.
• Establish a strong external reputation through scientific publication and presentation.

Minimum Qualifications

• PhD in a scientific discipline with 7+ years of experience, or MS with 13+ years, or BS with 15+ years of experience.
• Outstanding expertise in advancing drug discovery programs, particularly in target identification, target-specific screening cascades, and molecular immunology.
• Experience in celiac disease and/or immuno-oncology a plus.
• Ability to keep current with scientific advancements including competitive landscape, new technology, research portfolio, and new partnerships.
• Demonstrated excellence in guiding drug discovery teams to make data-driven, go/no-go decisions within established timelines.
• Scientific driver for research strategy with impact both within and outside area of function.

A key member of Janssen BioTherapeutics within Biologics Development Sciences, the Associate Scientific Director, Translational PK/PD develops fit-for-purpose M&S strategies and conducts mechanistic PK/PD studies to support biologics programs from discovery through IND/CTA filing. Collaborating with stakeholder departments across therapeutic areas, the role enables first-in-human dose predictions and timely program decisions that advance protein, cell, and gene therapeutics to early clinical stages.

Delivery Expectations

• Lead the development of fit-for-purpose M&S strategies to inform target and modality selection, molecule design, lead optimization, and clinical dose predictions to enable first-in-human studies.
• Design critical path experiments and deliver high-quality data and analysis to effectively drive program decisions.
• Lead the writing and review of relevant sections of internal and regulatory submission documents for biologics.
• Identify and enhance processes and workflows, develop innovative thinking, contribute to strategic decision making, and implement new methodologies as applicable.
• Mentor scientists and serve as JBio team leader as needed.

Technical Qualifications

• PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biological Sciences, Bioengineering, Chemical Engineering, or Applied Mathematics with at least 5 years of relevant experience (e.g., postdoc, industry).
• Extensive experience with quantitative approaches in describing pharmacology and/or PK/PD (preclinical or clinical) with demonstrated ability to apply quantitative tools to enable efficient drug development.
• Broad experience in mechanism-based PK/PD modeling, Quantitative Systems Pharmacology modeling, and research of biologic therapeutics highly preferred.
• Expertise and extensive hands-on experience in at least one industry-standard modeling and simulation software (e.g., Monolix, NONMEM, Matlab); proficiency in WinNonlin/Phoenix preferred.
• Strong publication record strongly preferred.
• Excellent communication skills with experience working on cross-functional teams and ability to work independently.