We are seeking an accomplished Clinical Pharmacology leader to guide the strategic direction of clinical pharmacology across the oncology development portfolio. Reporting to the Chief Medical Officer, this executive will be responsible for shaping clinical pharmacology strategies that support programs from early clinical evaluation through global registration.
The successful candidate will lead initiatives related to dose selection and optimization, pharmacokinetic and pharmacodynamic analyses, exposure-response modeling, and regulatory strategy while helping drive data-informed development decisions. This individual will play an integral role within the Clinical Development leadership team and will collaborate across scientific and operational functions to ensure quantitative clinical pharmacology is embedded throughout the development process.
This is an opportunity for an experienced scientist who enjoys working in a dynamic biotechnology environment, building organizational capabilities, and contributing to the advancement of innovative oncology therapies. The ideal candidate combines scientific depth, strategic thinking, and collaborative leadership with a passion for translating complex data into meaningful development decisions.
Primary Responsibilities:
Define and oversee clinical pharmacology strategies supporting current and future oncology assets throughout the product development lifecycle.
Serve as the organization's senior subject matter expert in clinical pharmacology and provide strategic guidance to executive leadership.
Lead development plans addressing dose selection, dose optimization, food effect studies, drug-drug interactions, cardiac safety assessments, organ impairment evaluations, and special population considerations.
Apply model-informed drug development approaches, including pharmacokinetic/pharmacodynamic modeling, population PK analyses, exposure-response assessments, and pharmacometric methodologies to optimize development strategies.
Direct preparation and scientific review of clinical pharmacology content for protocols, Investigator's Brochures, Clinical Study Reports, regulatory submissions, briefing packages, and health authority responses.
Represent the clinical pharmacology function during interactions with regulatory agencies, including the FDA and international authorities.
Work closely with Clinical Development, Translational Sciences, Biomarkers, Regulatory Affairs, Biostatistics, Clinical Operations, Data Management, Medical Writing, and other cross-functional partners to support integrated development plans.
Provide scientific leadership for study design, protocol development, program governance, and key portfolio decisions.
Oversee external collaborators, contract research organizations, and specialized modeling partners to ensure timely, high-quality execution.
Build and develop the Clinical Pharmacology function by establishing best practices, mentoring team members, and strengthening organizational capabilities.
Monitor scientific advancements and emerging technologies in clinical pharmacology to enhance development programs and future pipeline opportunities.
Present scientific strategies, analyses, and recommendations to senior leadership, governance committees, regulatory agencies, scientific conferences, and external collaborators.
Qualifications: Required
Advanced degree (PhD, PharmD, MD, or equivalent) in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, or a related scientific discipline.
At least 12 years of industry experience supporting drug development within biotechnology or pharmaceutical organizations, including significant experience in oncology.
Proven leadership of clinical pharmacology activities spanning first-in-human studies through later stages of clinical development.
Extensive knowledge of pharmacokinetics, pharmacodynamics, population PK, exposure-response analyses, modeling and simulation, and dose optimization strategies.
Experience supporting Investigational New Drug (IND) applications and collaborating with regulatory agencies such as the FDA and other international authorities.
Strong understanding of global regulatory expectations, including FDA, EMA, and ICH clinical pharmacology guidance.
Demonstrated ability to influence development strategy and lead cross-functional initiatives in a matrixed environment.
Experience working with small-molecule oncology therapeutics.
Outstanding written, verbal, presentation, and leadership skills.
Preferred:
Experience with precision medicine or biomarker-guided oncology development programs.
Familiarity with physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), or related advanced modeling methodologies.
Experience contributing to major global marketing applications, including NDA, BLA, or equivalent submissions.
Previous success creating, expanding, or leading a Clinical Pharmacology function within an emerging biotechnology organization.
Numbers & Facts
Location
Hybrid, Lexington, MA
Skills
Analysis Skillsunmatched
Best Practicesunmatched
Biomarkersunmatched
Biostatisticsunmatched
Biotech and Pharmaceuticalunmatched
Brochuresunmatched
Cardiologyunmatched
Clinical Assessmentunmatched
Clinical Data Managementunmatched
Clinical Pharmacologyunmatched
Clinical Practices/Protocolsunmatched
Clinical Supportunmatched
Clinical Trialunmatched
Conferencesunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
Develop Methodologiesunmatched
Drug Developmentunmatched
Drug Interactionsunmatched
Embedded Systemsunmatched
Emerging Technologyunmatched
FDA (Food and Drug Administration)unmatched
ICH Regulationsunmatched
International Marketingunmatched
Investigational New Drug (IND)unmatched
Leadershipunmatched
Marketing Softwareunmatched
Medical Writingunmatched
Medicineunmatched
Mentoringunmatched
Oncologyunmatched
Operations Managementunmatched
Pharmacodynamicsunmatched
Pharmacokineticsunmatched
Pharmacologyunmatched
Presentation/Verbal Skillsunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Protocol Designunmatched
Regulationsunmatched
Regulatory Reportsunmatched
Regulatory Submissionsunmatched
Simulationunmatched
Small Moleculesunmatched
Strategic Analysisunmatched
Strategic Planningunmatched
Team Playerunmatched
Time Managementunmatched
Translational Researchunmatched
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