Executive Director, DMPK

Executive Director, DMPK Job Description :

About the Role :

Develops strategic plans, objectives and policies for overall function. Leads the Preclinical Pharmacokinetics function within the Preclinical Development organization.

Provides scientific leadership and oversight to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized and developed.

Plays a key role in the discovery and advancement of Company’s development compounds. Works with Company colleagues to participate in all stages of Preclinical Pharmacokinetic assessments, from compound screening through to IND and NDA regulatory submissions.

Represents Preclinical Development on Research and Development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Preclinical Pharmacokinetics.

Your Contributions (include, but not limited to) :

• Provides strategic, functional leadership and oversight to the Preclinical Pharmacokinetic function within Preclinical Development
• Responsible for the development and enablement of departmental strategies to evaluate Preclinical Pharmacokinetics including ensuring continued expansion and / or updating of training, techniques and / or equipment
• Leads and manages the conduct, interpretation and reporting of preclinical pharmacokinetic studies
• Works 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
• Designs & conducts Preclinical Pharmacokinetic and Toxicokinetic / Pharmacokinetic / Pharmacodynamic studies in support of clinical development compounds
• Oversees the preparation of Preclinical Pharmacokinetic sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.).
• Actively leads / participates in research-stage and development-stage program teams from both a strategic and tactical level
• Prepares data summaries and presents results to peers, colleagues, the Management Committee and regulatory agencies
• Prepares Standard Operating Procedures (SOPs) as needed to guide the Preclinical Pharmacokinetics activities
• Performs other duties as assigned

Requirements :

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 OR

• MS in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 15+ years of similar experience noted above OR
• 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
2 days ago