Director / Sr. Director of DMPK
Redwood City , CA /
Full Time Employee (FTE)
We are seeking a Director / Senior Director DMPK that is highly motivated to join our team and work on-site at an exciting biotech start-up in Redwood City. The ideal candidate for the role is experienced in contributing to drug discovery and development projects and possesses broad expertise in DMPK. In addition, the candidate has experience in DMPK focused on small molecule lead optimization for discovery research programs as well as preclinical and clinical drug development. The Dir./ Sr. Dir. DMPK will be responsible for leading DMPK interactions with a multi-disciplinary team to facilitate the successful achievement of lead optimization programs and the progression of drug candidates in preclinical development.
- Develop strategies to ensure effective achievement of nonclinical and clinical drug development objectives.
- Manage the design and preparation of nonclinical and clinical PK development strategies and study protocols, performing and supervising PK analyses, and preparation of study reports.
- Oversee external CROs to support research objectives.
- Work within research and development, closely with clinical operations, biostatistics, data management, chemistry, toxicology and pharmaceutical sciences areas.
- Provide scientific expertise on chemical lead optimization programs and collaborate with Medicinal Chemists and Biologists to optimize the DMPK properties of candidate drugs.
- Provide feedback and direction for regulatory submissions and project related document review.
- Support preclinical evaluation of drug candidates in development programs.
Preferred Additional Skills
- Build and maintain effective working relationships throughout the organization to achieve goals.
- Maintain knowledge of state-of-the–art principles and theories and possess advanced knowledge of scientific principles and concepts in field of expertise.
- Proactively contribute to and demonstrate scientific leadership in scientific literature, Intellectual Property, manuscripts for publication, conferences and seminars.
- Make decisions impacting nonclinical and clinical pharmacology goals and the relevance of individual clinical trials.
- Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.
- Exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Act independently to determine methods and procedures on new assignments.
Education and Experience Requirements
- PhD degree in Chemistry, Biochemistry or related discipline or a MA/MS with min 12 + years of pharmaceutical industry experience.
- A strong background in ADME and pharmacokinetics/pharmacodynamics with relation to small molecule lead optimization.
- Industrial experience and demonstrated technical knowledge in multiple DMPK areas.
- A broad understanding of the experimental DMPK methodologies and approaches, in vitro and in vivo, utilized in chemical lead optimization.
- Ability to collaborate with multiple disciplines in drug discovery and provide outstanding guidance to medicinal chemists and Biologists in the lead optimization process.
- Experience conducting innovative research in DMPK applied to the discovery of novel drug candidates to achieve targeted milestones in a fast paced environment.
- Extensive knowledge of preclinical drug development and in the preparation of regulatory documents, e.g. INDs and NDAs.
- Self-motivated, detail oriented leader with exceptional organizational and leadership and interpersonal skills.
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.