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Executive Director, DMPK
2 months ago
We are seeking a highly experienced and skilled Executive Director to lead our Preclinical Pharmacokinetics function within the Preclinical Development organization. As a key member of our team, you will be responsible for developing strategic plans, objectives, and policies for overall function, providing scientific leadership and oversight to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized and developed.
Key Responsibilities:- Develop and implement departmental strategies to evaluate Preclinical Pharmacokinetics, including ensuring continued expansion and/or updating of training, techniques, and equipment.
- Lead and manage the conduct, interpretation, and reporting of preclinical pharmacokinetic studies.
- Work with Research and Preclinical Development colleagues to establish optimal lead candidate characteristics, develop appropriate testing schemes, and design, conduct, and report on preclinical studies intended to characterize potential drug candidates.
- Design and conduct Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies in support of clinical development compounds.
- Oversee the preparation of Preclinical Pharmacokinetic sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.).
- Actively lead/participate in research-stage and development-stage program teams from both a strategic and tactical level.
- Prepare data summaries and present results to peers, colleagues, the Management Committee, and regulatory agencies.
- Prepare Standard Operating Procedures (SOPs) as needed to guide the Preclinical Pharmacokinetics activities.
- Bachelor's in chemistry, life sciences, or closely related discipline and 17+ years of pharmaceutical/biotech experience, with extensive management experience. Experience in managing preclinical Contract Research Organizations. Experience managing preclinical scientists and preparation of INDs, CTDs, NDAs, and MAAs. Experience with silico modeling and simulation tools is beneficial.
- MS in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 15+ years of similar experience noted above.
- PhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline or PharmD and 12+ years of similar experience noted above.
- Demonstrated leadership of a Preclinical Pharmacokinetic function.
- Extensive experience in 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 good problem-solving skills.
- Knowledgeable of and current on regulatory guidance.
- Acts as a 'trusted advisor' across the company and may be recognized as an external expert.
- Provides strategy, vision, and direction regarding issues that may have company-wide impact.
- Requires in-depth knowledge of the functional area, business strategies, and the company's goals.
- Possesses industry-leading knowledge.
- Ability to work strategically in a cross-functional team and matrix environment.
- Excellent written, presentation, and verbal communication skills.
- Exceptional leadership, coaching, employee development skills.
- Demonstrated ability to negotiate and influence others with or without authority at all levels of the organization.
