Director – Clinical Pharmacology

Description:

Redeployment is partnering with a cutting-edge biotech company dedicated to transforming cancer treatment through innovative drug development. We are seeking a highly skilled Director of Clinical Pharmacology to lead and shape clinical pharmacology strategies across a portfolio of small molecule oncology assets.

This critical leadership role requires expertise in dose optimization, pharmacokinetics (PK), pharmacodynamics (PD), and drug interaction assessments, while also ensuring regulatory compliance and contributing to successful IND, NDA, and other key filings. The Director of Clinical Pharmacology will play a pivotal role in translating early-stage science into clinically meaningful therapies for cancer patients.

Key Responsibilities:

📊 Strategic Leadership:

• Develop and execute comprehensive clinical pharmacology and pharmacometrics strategies to guide dose selection, dose optimization, and overall clinical development of small molecule candidates.
• Integrate clinical pharmacology insights into cross-functional development plans, collaborating closely with teams across Clinical Development, DMPK, Translational Medicine, Regulatory Affairs, Biometrics, and CMC.

📄 Study Design & Oversight:

• Design and oversee clinical pharmacology studies, including protocol development, study planning, data analysis, and results interpretation.
• Ensure robust PK/PD analysis and population modeling across programs.

📑 Regulatory Documentation & Submissions:

• Author and review clinical pharmacology sections for key regulatory submissions, including INDs, NDAs, Investigator Brochures (IB), and responses to Health Authority inquiries.
• Provide expert representation of clinical pharmacology data during regulatory interactions.

🔬 Data Analysis & Integration:

• Review, interpret, and present PK/PD data, ensuring timely delivery of insights to internal teams, leadership, and external stakeholders.
• Partner with external vendors and consultants, ensuring compliance with quality standards, data integrity, and program timelines.

📣 Cross-Functional Collaboration:

• Act as a scientific bridge between preclinical and clinical development, ensuring data continuity and alignment across stages.
• Present clinical pharmacology insights to senior management, development teams, investigators, and regulatory authorities to drive decision-making.

Qualifications:

🎓 Education:

• Ph.D. (or equivalent) in Pharmacokinetics, Pharmaceutical Sciences, Clinical Pharmacology, or a related field.

📋 Experience:

• Minimum 7 years of industry experience (or equivalent post-doctoral experience) in clinical pharmacology within the biotech or pharmaceutical industry.
• Oncology drug development experience is strongly preferred.
• Proven track record of leading clinical pharmacology strategy for small molecule programs.
• Strong regulatory experience, including contributions to NDA/BLA/MAA filings and direct involvement in Health Authority interactions.

📊 Technical Expertise:

• Proficient in interpreting PK, PD, and PK/PD modeling data to inform dose selection, dose optimization, and clinical trial design.
• Hands-on experience with clinical pharmacology data interpretation tools and modeling software is preferred.

💬 Communication Skills:

• Excellent ability to translate complex pharmacology data into clear insights for cross-functional teams, leadership, and external stakeholders.
• Strong writing skills for regulatory documents and study reports.

Cultural Competencies:

🤝 Collaborative & Cross-Functional: Works seamlessly across clinical, regulatory, and research teams, aligning clinical pharmacology strategy with broader development goals.
📊 Data-Driven & Strategic: Applies deep pharmacology insights to shape strategic decisions and guide clinical development.
🔍 Detail-Oriented: Maintains rigorous attention to detail in protocol design, data analysis, and reporting.
🎙️ Effective Communicator: Presents complex data in a clear, concise, and compelling manner to both internal and external audiences.

Benefits:

💵 Compensation: 13750 USD to 22083 USD per month (DOE)
🏥 Comprehensive Benefits Package:

• Medical Insurance (HMO and PPO plans)
• Dental and Vision Coverage
• Prescription Drug Coverage
• Flexible Spending Accounts (Healthcare & Dependent Care FSAs)
• Life Insurance & AD&D Coverage
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program (EAP)

About the Company:
Our client, a highly respected biotech company, is advancing innovative therapies to revolutionize cancer care. Led by experienced scientific and business leaders, they are committed to scientific rigor, patient focus, and transformative clinical development.

About Redeployment:
At Redeployment, we specialize in connecting top talent with life science innovators. Our mission is to match professionals with career opportunities that align with their passion, expertise, and goals. By understanding company culture, team dynamics, and growth trajectories, we ensure the right people land in the right roles—driving mutual success.