Director of DMPK (Drug Metabolism and Pharmacokinetics)

Job Summary

We are seeking a highly motivated and experienced Director of DMPK at our Doylestown, PA site. The candidate will work within the discovery team and be responsible for ADME/DMPK aspects of all of our peptide discovery and development pipeline, including lead identification/optimization, FIH translation, and non-clinical packages to support regulatory filings. The candidate must 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 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 & 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.

Important Notes

* This is an ON-SITE position! Must be willing and able to relocate to the Doylestown, PA area.

* Compensation will be based on prior experience and will be discussed during interview process. If you have any specific salary requirements, please note them.

* If you would prefer to submit your resume directly, please send it to hr@pinnaclemedicines.com for review.

Job Type: Full-time

Pay: From $1.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday
• No weekends

Supplemental Pay:

• Bonus opportunities

Application Question(s):

• Do you have at least 7 years of relevant DMPK experience in a biotechnology or pharmaceutical environment?

Education:

• Doctorate (Required)

Experience:

• Management: 3 years (Preferred)
• Budgeting: 3 years (Preferred)

Experience:

• Management: 3 years (Preferred)
• Budgeting: 3 years (Preferred)

Ability to Relocate:

• Doylestown, PA 18901: Relocate before starting work (Required)

Work Location: In person