Director, DMPK
Zenas BioPharmaWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Zenas is currently looking for Director of DMPK reporting to Head of Nonclinical Development. This highly motivated and experienced individual will lead Zenas drug metabolism and pharmacokinetics (DMPK) functions. The successful candidate will be responsible for developing and executing DMPK strategies across all preclinical- and clinical-stage development candidates. This individual will serve as the hands-on scientific and strategic leader all nonclinical aspects for drug absorption, distribution, metabolism, and excretion (ADME) following available regulatory guidance from global regulatory agencies. He/She will be working closely with cross-functional teams including Toxicology, Clinical Pharmacology, Regulatory Affairs, and Program Management to advance and expand our pipelines. The role requires strong scientific expertise, leadership skills, and proven experience in a fast-paced biotech environment by managing external CROs and collaborating closely with internal project teams.
Responsibilities
- Define and execute DMPK strategy and plans across all development candidates at preclinical, early and late clinical development phases
- Design and execute preclinical ADME/PK studies via an outsourcing model working closely with service providers such as CROs and interpret study data for DMPK findings as a scientific leader
- Represent DMPK on a variety of interdisciplinary teams
- Manage CROs and collaborate with cross-functional teams by providing DMPK data package in a timely fashion.
- Author and review regulatory documents for submission such as INDs, CTAs, NDAs etc.
Qualifications
- PhD in Pharmacokinetics, Pharmaceutical Science or related discipline with 6+ years biopharma experience (or 10+ years with MS/BS degree).
- DMPK expertise in small molecules and biologics. Other novel modalities are preferred but not required.
- Strong leadership, communication, and cross-functional collaboration skills.
- In-depth knowledge and understanding of DMPK principles; strong hands-on experience with relevant DMPK tools such as WinNonlin
- Experience with regulatory interaction and submissions