Job Summary
An innovative biotech is looking for a highly motivated and experienced Director of DMPK to join the team at the Doylestown, PA site. The successful candidate will be responsible for ADME/DMPK aspects of our peptide discovery and development pipeline, including lead identification/optimization, FIH translation, and non-clinical packages to support regulatory filings. The ideal candidate will have demonstrated an ability to work collaboratively in a fast-paced, dynamic environment with excellent scientific and communication skills.
Key Responsibilities
- Lead and manage ADME and DMPK functions, design and implement strategies for ADME and DMPK studies, interpret data and integrate it into overall project plans.
- Design and execute mechanistic and translational studies to evaluate the pharmacokinetic and metabolic properties of macrocyclic peptides to influence design, lead selection, and drive PK/PD translation and human dose prediction.
- Advance the use of modeling techniques to accelerate lead selection/optimization and the progression of clinical candidates with high probability of success.
- Collaborate with internal and external partners to provide strategic DMPK guidance, and plan and execute DMPK studies to support preclinical and clinical drug development.
- Manage DMPK budget and provide budget planning.
- Provide DMPK expertise to project teams, ensure compliance with industry regulations and standards in all DMPK activities, and advise on the DMPK aspects of regulatory submissions and author regulatory documents from FIH through registrational filing.
- Stay informed of external advancements of DMPK for peptide drug discovery and contribute to the evaluation and implementation of cutting-edge technologies and methodologies.
- Participate in due diligence and business development activities as needed.
Qualifications
- Requires PhD in Pharmacokinetics, Pharmacology, Biochemistry, or a related discipline with a minimum of 7 years of relevant DMPK experience in a biotechnology or pharmaceutical environment.
- At least 3 years of management experience, including staff development and budget responsibility.
- Demonstrated expertise and successful experiences of independently leading DMPK efforts in small molecule or peptide drug discovery teams within a fast-paced, dynamic, and collaborative environment.
- Capable of analyzing and interpreting complex ADME/DMPK data, ability to extract preclinical PKPD/efficacy and safety data and translate to human setting to guide therapeutic design and candidate selection, and implementation of effective de-risking plans.
- Strong problem-solving and leadership skills, highly motivated and self-driven with a keen interest in staying at the forefront of DMPK science and technology.
- Strong knowledge of relevant regulations and industry standards.
Preferred Experience and Skills
- Prior experience with multiple therapeutic modalities (e.g., small molecules, peptides, biologics, etc.).
- In-depth understanding and experience in discovery bioanalytical science, including immunoassay, LC/MS.
- In-depth understanding of modeling principles, including noncompartmental analysis. Hands-on experience with modeling using various software packages.
- Knowledge of novel and translatable in vitro cellular models and/or in vivo models.
- Strong knowledge of relevant regulations and industry standards, and experience with regulatory submissions are highly desirable.
