Executive Director, DMPK

About The Role:
- Develops strategic plans, objectives, and policies for overall function.
- Leads the Preclinical Pharmacokinetics function within Preclinical Development.
- Provides scientific leadership and oversight to identify and appropriately characterize/develop clinical candidates.
- Plays a key role in discovery and advancement of development compounds.
- Participates in all stages of Preclinical Pharmacokinetic assessments (from compound screening through IND/NDA submissions).
- Represents Preclinical Development on Research & Development teams and ensures timely dissemination of Preclinical Pharmacokinetics.

Your Contributions (include, but not limited to):
- Provides strategic, functional leadership and oversight to Preclinical Pharmacokinetics.
- Develops and enables departmental strategies to evaluate Preclinical Pharmacokinetics, including expanding/updating training, techniques, and/or equipment.
- Leads and manages conduct, interpretation, and reporting of preclinical pharmacokinetic studies.
- Works with Research and Preclinical Development colleagues to define lead candidate characteristics, testing schemes, and preclinical study design/conduct/reporting.
- Designs and conducts Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies for clinical development compounds.
- Oversees preparation of Preclinical Pharmacokinetic sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.).
- Leads/participates in program teams at research and development stages (strategic and tactical).
- Prepares data summaries and presents results to peers, committees, and regulatory agencies.
- Prepares SOPs as needed to guide Preclinical Pharmacokinetics activities.
- Performs other duties as assigned.

Requirements (Qualifications & Skills):
- Bachelor’s in chemistry/life sciences (or closely related) + 17+ years pharma/biotech experience with extensive management experience; experience managing preclinical Contract Research Organizations and scientists; preparation of INDs, CTDs, NDAs, and MAAs; silico modeling/simulation tools beneficial.
OR
- MS in Pharmacokinetics/Pharmaceutical Sciences (or closely related) + 15+ years similar experience.
OR
- PhD in Pharmacokinetics/Pharmaceutical Sciences (or closely related) or PharmD + 12+ years similar experience.
- Demonstrated leadership of a Preclinical Pharmacokinetic function.
- Extensive experience managing preclinical Contract Research Organizations.
- Excellent knowledge of preparation of INDs, CTAs, NDAs, and MAAs.
- Working knowledge of in silico modeling and simulation tools.
- Proactive/innovative with strong problem-solving skills.
- Knowledge of and current awareness of regulatory guidance.
- Acts as a trusted advisor; may be recognized as an external expert.
- Provides strategy/vision/direction with potential company-wide impact; in-depth functional area and business/goal knowledge.
- Ability to work strategically in cross-functional, matrix environments.
- Excellent written, presentation, and verbal communication.
- Exceptional leadership, coaching, and employee development.
- Demonstrated ability to negotiate and influence at all organizational levels.

Application instructions:
- Apply even if your experience/qualifications don’t match the job description exactly.