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United States
Onsite
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Clinical Pharmacology based in the United States.
The Associate Director, Clinical Pharmacology will play a strategic leadership role in shaping and executing clinical pharmacology development plans across multiple drug development programs. This position focuses on integrating clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics expertise to support scientific innovation and regulatory success. You will lead multidisciplinary teams, oversee clinical study strategies, and translate complex scientific data into actionable development decisions. Working closely with clinical, regulatory, and CMC stakeholders, you will help advance therapeutic programs from early development through later clinical phases. The role also involves contributing to regulatory submissions, scientific publications, external collaborations, and business development assessments. This is an opportunity to influence drug development strategies while driving meaningful advances in clinical research and patient care.
As an Associate Director, Clinical Pharmacology, you will lead clinical pharmacology and PK/PD activities across multiple development programs, ensuring scientific excellence, regulatory alignment, and successful execution of development strategies. Your responsibilities will include:
Design and oversee Phase 1–4 clinical studies and establish clinical pharmacology strategies, serving as the primary functional representative for assigned projects.
Develop and execute clinical pharmacology strategies while leading multidisciplinary teams, data analyses, and scientific interpretation.
Provide scientific context for research questions by integrating mechanisms of action (MoA), disease-specific knowledge, internal and external data, analytical plans, and model results.
Generate new pharmacokinetic and pharmacodynamic (PK/PD) study proposals and lead their development and implementation.
Author and review regulatory and scientific documentation, including clinical protocols, study reports, population PK reports, exposure-response analyses, Common Technical Documents (CTDs), product labeling sections, investigator brochures, and scientific white papers.
Lead clinical pharmacology and biopharmaceutics meetings and represent the function in Clinical Strategy Teams, Asset Development Teams, and other cross-functional forums.
Coordinate small multidisciplinary teams across clinical pharmacology groups to establish unified scientific positions and support clinical, chemistry, manufacturing, and controls (CMC), and regulatory decisions.
Monitor scientific, technical, and regulatory developments, identifying emerging opportunities, risks, strengths, and challenges to refine development strategies.
Author scientific publications and present research findings at national and international conferences.
Build relationships with key opinion leaders (KOLs), external experts, and other scientific stakeholders.
Conduct scientific due diligence assessments, summarize findings, and represent clinical pharmacology in business development activities.
Represent the Clinical Pharmacology function during regulatory meetings and support interactions with regulatory authorities.
Partner with clinical pharmacology and pharmacometrics leadership to critically evaluate scientific, technical, and strategic aspects of development programs.
The ideal candidate is an accomplished clinical pharmacology professional with extensive experience in drug development, PK/PD modeling, and scientific leadership. You should demonstrate strong technical expertise, strategic thinking, and the ability to influence decisions across multidisciplinary teams and external stakeholder groups. The following qualifications are expected:
PhD with typically at least 4 years of relevant experience; PharmD with typically at least 6 years; Master's degree or equivalent education with typically at least 12 years; or Bachelor's degree or equivalent education with typically at least 14 years of relevant experience.
Relevant experience in pharmacokinetics (PK), physiologically based pharmacokinetics (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) modeling, pharmacometrics, systems pharmacology, drug metabolism, or transporters.
Proven scientific track record and strong technical expertise in clinical pharmacology and drug development.
Experience developing and executing clinical pharmacology strategies across multiple development programs.
Strong understanding of clinical study design, pharmacokinetic and pharmacodynamic analyses, exposure-response relationships, and regulatory requirements.
Experience preparing scientific and regulatory documentation, including clinical study reports, population PK analyses, regulatory submissions, and product labeling materials.
Ability to interpret complex scientific data and communicate findings in the context of research and development objectives.
Demonstrated experience leading multidisciplinary teams and influencing cross-functional stakeholders.
Excellent interpersonal and communication skills, with the ability to engage effectively with internal functional representatives, external experts, and KOLs.
Strong strategic thinking and an enterprise-wide perspective, balancing immediate business objectives with long-term development priorities.
Ability to identify scientific opportunities, anticipate challenges, and develop innovative solutions.
Strong leadership capabilities, including the ability to:
Deliver business results while positioning development programs for long-term success.
Demonstrate persistence and resilience in advancing promising ideas and initiatives.
Act respectfully while having the courage to challenge existing approaches when necessary.
Connect diverse concepts and generate original scientific and strategic ideas.
Influence colleagues and stakeholders to achieve cross-functional alignment.
Take full accountability for delegated responsibilities while empowering others to own their commitments.
Competitive compensation package based on experience, qualifications, and geographic location.
Comprehensive paid time off, including vacation, holidays, and sick leave.
Medical, dental, and vision insurance.
401(k) retirement savings plan.
Eligibility to participate in long-term incentive programs.
Opportunity to contribute to innovative drug development programs across multiple therapeutic areas.
Exposure to multidisciplinary scientific teams and collaboration with leading experts and key opinion leaders.
Opportunities to present research at national and international scientific conferences.
Opportunity to influence clinical development strategies and contribute to advances in patient care.
