Director, DMPK
San Diego, CA

Director DMPK (possibility for Senior Director title)

Top Tier Pharmaceutical company is expanding their high profile DMPK Team:

About the Role:

Develops strategic plans and objectives for area of responsibility, including working with Research, Clinical Pharmacology and Bioanalytical colleagues to develop overall Preclinical Pharmacokinetic Strategies for subsequent ratification by project teams. Plays a key role in the discovery and advancement of company’s development compounds, including small molecules and biologics (peptides, proteins and antibodies). Works with colleagues to participate in all stages of Preclinical Pharmacokinetic assessments, from compound screening through to IND and NDA regulatory submissions. Working with Research, Bioanalytical and Clinical Pharmacology subject matter experts, provides scientific leadership to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized. 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 findings. Competitive Base Salary, plus 35% bonus, Stock/RSUs and other LTIs. ROBUST RELOCATIONS PACKAGE available. Position is in-office in San Diego Headquarters.

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Your Contributions (include, but are not limited to):

• Leads and manages the conduct, interpretation and reporting of preclinical pharmacokinetic studies

• Works with Research and other Preclinical Development subject matter experts to establish optimal lead candidate characteristics, develop appropriate testing schemes, and design, conduct and report on preclinical PK 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 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 and the Management Committee

• 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 15+ years of pharmaceutical/biotech 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 13+ years of similar experience noted above OR
• PhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 10+ years of similar experience noted above
• Has extensive knowledge of Preclinical Pharmacokinetics.

• Extensive knowledge of managing clinical Contract Research Organizations

• Excellent knowledge of activities/work required in preparation of INDs, CTAs, NDAs, and MAAs

• Working knowledge of in silico modeling and simulation tools
• Working knowledge of Preclinical Pharmacokinetic characterization of Biologics (peptides, proteins, antibodies)

• Knowledgeable on current regulatory guidance’s
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Ability to apply advanced analytical thought and judgment
• Strong leadership, coaching, employee development skills
• Ability to influence others with or without authority at all levels of the organization
• Proactive, innovative, with good problem-solving skills
• Ability to work in a cross functional team and matrix environment
• Excellent written, presentation, and verbal communication skills
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