What are the responsibilities and job description for the Director, Clinical Pharmacology position at Enigma Search?
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 :
