Director, Clinical Pharmacology
HybridLondon, England, United Kingdom
Job Summary
Build and own clinical pharmacology and pharmacometric capability to support product development goals, setting standards for excellence and championing innovative approaches. Act as the Clinical Pharmacology lead for multiple concurrent programmes across indications and therapeutic modalities, overseeing clinical pharmacology input into study design from IND-enabling through Phase 3 trials. Lead modelling and simulation approaches, non-clinical to clinical PK/PD, DDI risk assessment, PBPK, population PK/PD, and QSP approaches to characterise developability and support dose selection. Lead external collaborations and CRO partnerships, ensuring effective execution against timelines and budgets. Author regulatory documents including Investigator's Brochures, INDs, and NDA/BLA/MAA submissions. Proactively incorporate AI-enabled approaches into workflows using data analytics to sharpen decision-making. Interface with cross-functional teams including DMPK, translational safety, biology, clinical operations, and regulatory affairs to embed clinical pharmacology considerations in development plans. Maintain rigorous documentation standards across modelling packages and study reports.
Required Qualifications
- A PhD, PharmD, or MD with a specialisation in DMPK, Pharmacometrics, in vivo/Clinical Pharmacology, or a related scientific discipline, or equivalent industry experience in a lead Quantitative Clinical Pharmacology position
- Significant experience in the pharmaceutical or biotech industry in Quantitative Clinical Pharmacology, spanning all stages of development
- A strong foundation of in vivo Pharmacology and Clinical Pharmacology principles and quantitative drug development
- Demonstrable experience applying advanced quantitative modelling (proven proficiency in core pharmacometric software such as NONMEM, R, Monolix, WinNonlin, GastroPlus, SimCyp), data analytics, and emerging AI-enabled approaches to support evidence-based decision making
- Understanding of the regulatory landscape and how to integrate diverse data (nonclinical, translational and clinical) for efficient development
- Outstanding communication skills, with a clear ability to translate complex quantitative data into actionable strategic messages for cross-functional teams, stakeholders and senior leadership
- Comfortable working in a matrixed environment, balancing multiple stakeholders and contributing effectively across teams
- Take ownership of your work, proactively seek opportunities to contribute, and enable others to do their best work
- Communicate openly and directly, give and receive feedback constructively, and handle challenging conversations with respect
- Actively seek out diverse perspectives, build strong working relationships, and contribute to shared goals across teams
- Embrace challenges with openness and resilience, set high standards for yourself, and strive to deliver meaningful outcomes
Desired Qualifications
- Experience across therapeutic modalities, small molecules, biologics and novel platforms alike
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.