Director, Clinical Pharmacology - Enigma Search : Job Details

Are you a seasoned professional with a passion for Clinical Pharmacology and Early Drug Development? Our client, a pioneering biotech company committed to advancing human healthspan, is looking for a Director, Clinical Pharmacology to join their innovative team. This is a unique opportunity to lead the translation of groundbreaking preclinical discoveries into clinical development, shaping the future of therapies for aging-related conditions.

Key Responsibilities:

• Lead and represent the Clinical Pharmacology function in cross-functional teams to design and execute early clinical development plans.
• Develop and oversee Clinical Pharmacology strategies, including first-in-human protocols, to evaluate safety, tolerability, pharmacokinetics, and other key studies (ADME, DDI, TQT, renal and hepatic impairment).
• Contribute to experimental medicine studies for proof-of-mechanism in aging and age-related diseases.
• Play a central role in dose selection strategies for Phase 2 studies.
• Author and review clinical protocols, study reports, investigational brochures, regulatory submissions (IND/CTAs), and statistical analysis plans.
• Collaborate with internal teams (Research, Biomarkers, Regulatory Affairs, etc.) and external partners (CROs, study vendors) to drive project success.
• Train CROs and study site personnel on protocols and address protocol-related queries.
• Evaluate and oversee CROs and vendors to ensure study quality.

What You Have:

• An advanced degree (PhD, PharmD, or MS) in a field relevant to pharmaceutical development.
• Expertise in Modeling and Simulation (preferred).
• 8+ years of experience in early clinical drug development, with strong proficiency in first-in-human, ADME, DDI, and TQT studies.
• Hands-on experience in Phase 0 through Phase 2 trial methodology and clinical trial deliverables.
• In-depth knowledge of pharmacokinetics and clinical pharmacology, including managing CROs or development partners.
• Familiarity with ICH GCP guidelines, FDA, and EMA regulations.
• Exceptional communication skills, leadership abilities, and a detail-oriented mindset.
• The ability to work collaboratively and influence cross-functional teams.
• A commitment to being onsite at least 4 days per week.