Job Description:
As the Director of Clinical Pharmacology, you will play a key role in shaping the clinical pharmacology strategy for our biologics portfolio. You will lead clinical pharmacology teams, collaborate closely with other departments such as regulatory affairs, clinical development, and drug safety, and provide expert guidance on pharmacokinetics, pharmacodynamics, and dosing strategies for our biologic therapies.
Key Responsibilities:
Lead the clinical pharmacology strategy for biologic products, from early-phase clinical trials through to regulatory submission and approval.
Design and implement clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose escalation, and biomarker studies.
Analyze and interpret clinical pharmacology data to support decision-making in clinical development and regulatory filings.
Collaborate with clinical, regulatory, and non-clinical teams to ensure alignment and timely delivery of program objectives.
Provide leadership and mentorship to the clinical pharmacology team, fostering a culture of excellence, innovation, and collaboration.
Communicate clinical pharmacology strategies and results to internal stakeholders, regulatory authorities, and external partners.
Stay updated with industry trends, regulatory requirements, and scientific advancements in clinical pharmacology and biologics.
Qualifications:
Advanced degree in Pharmacology, Pharmaceutical Sciences, or a related field (PhD, PharmD, or MD preferred).
Minimum of 8-10 years of experience in clinical pharmacology within the biopharmaceutical industry, with a focus on biologics.
Strong experience in the design, implementation, and analysis of clinical pharmacology studies for biologic therapies.
In-depth understanding of pharmacokinetics, pharmacodynamics, and modeling & simulation techniques.
Familiarity with regulatory requirements (FDA, EMA) for biologic products, including clinical trial designs and data submissions.
Proven track record of leadership and team management skills.
Excellent communication skills and the ability to work cross-functionally in a dynamic, fast-paced environment.
Ability to think strategically and contribute to the overall success of the clinical development program.
