Executive Director, DMPK
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for an Executive Director, DMPK
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops the strategy and direction for nonclinical DMPK processes and procedures.
- Communicates the DMPK development strategy within the company.
- Leads a team of consultants, contracts, academic partners to achieve desired outcome across the portfolio.
- Serves as an active participant in project teams.
- Guides project teams to characterize, select, and advance programs with ADME properties that are fit to the therapeutic profile; accomplishing this through designing and integrating data from in vitro and preclinical pharmacokinetic/toxicokinetic studies, and translating to predictions of human PK, PD, and safety.
- Collaborates with discovery and clinical development partners to create DMPK development plan, as well as identify and solve issues related to drug safety.
- Identifies and employs new technologies and strategies that address current and future ADME challenges.
- Ensures effective application and integration of ADME, PK and PK/PD studies in support of discovery and development programs.
- Delivers data on aggressive timelines to guide efforts in optimizing PK properties.
- Collaborates with other functions to select appropriate preclinical toxicology species and establish/refine PK-PD efficacy relationships.
- Delivers and communicates results to project teams to enable decision making.
- Authors and reviews DMPK sections on relevant documents and is accountable for their quality in support of regulatory submissions.
- Serves as a subject matter expert in composing responses to regulatory queries.
- Provides scientific and budgetary oversight and coordination of external vendors, ensuring high quality and on-time execution of DMPK studies.
- PhD or equivalent in related scientific discipline required.
- Must have a minimum of 10+ years of experience in pharmaceutical/biotech drug development.
- Familiarity with current FDA and EMA guidelines highly preferred.
- Experience in filing multiple INDs is a must; experience in filing NDAs or BLAs highly preferred.
- Requires experience with external vendor management.
- Must have the ability to collaborate across disciplines.
- An in-depth understanding of DMPK study design and data interpretation is required.
- Requires experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
- Must have hands-on experience working in a translational medicine/early development capacity.
- Experience leading virtual teams is highly preferred.
- Prior experience thriving in a small/entrepreneurial setting is preferred.
- Must be a team player with strong negotiation, problem-solving, and strategic influencing skills.
- Requires highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
- Requires the proven ability to perform successfully under stringent timelines and with changing and competing priorities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.