Exel
Senior DMPK Director
Alameda, CA · Director
Sponsorship not specified$183k-$260kDetected 10 days ago
Clinical TrialsPharmacologyResearchAnimal StudiesLeadershipCommunicationCollaborationPublic Speaking
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Green-card filing pattern in this occupation
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About the role
- The Senior Director contributes to growth of the Clinical Pharmacology and Pharmacometrics department and may mentor junior scientists.
- SUPERVISORY RESPONSIBILITIES: - No supervisory responsibilities.
- Teams work closely together, sharing ideas and solutions in a supportive atmosphere.
Responsibilities
- Lead the Translational IND- and NDA-enabling ADME work; characterize the ADME of molecules and collaborate to establish in vitro to in vivo correlations; ensure that all DMPK studies and analyses are consistent with regulatory guidance
- Closely partner with Clinical Pharmacology and pharmacometrics to ensure a seamless transition of molecules to development and generate the preclinical data needed to inform the Clinical Pharmacology development plans
- Work collaboratively with other functional partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives
- Prepare high quality regulatory documents including IND, CTA, and NDA filings; prepare DMPK components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and investigator brochures
- Support functional area reviews for due diligence evaluations
- Maintain external scientific visibility through publications
Requirements
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
- PhD degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 14 years of relevant experience in DMPK in the pharmaceutical industry
Nice to have
- Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology and progressing molecules into clinical trials
- Solid experience in utilization of physiologically-based and empirical modeling and simulations techniques to characterize drug-drug interactions and biopharmaceutics liabilities
- Experience with submission of IND/NDA/BLA and global marketing applications
- Experience with antibody drug conjugates is a plus
Skills
- Demonstration of independent thought/creativity in science and drug discovery
- Experience in applying emerging science and technologies to strengthen and improve research capabilities
- In-depth knowledge of current practices and issues in DMPK (including regulatory requirements), PKPD and translational sciences
- Demonstrates strong leadership; and has the ability to influence and make decisions
- Excellent collaborative verbal and written communication skills
- Able to work well with multi-disciplinary teams
- Exercises independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results
- Thrives in a fast-paced business environment
- Function in a highly matrixed team environment
- Minimum 12 years experience in DMPK
- Expert knowledge of in vitro and in vivo ADME studies
- Strong experience of managing external DMPK work at CROs
Compensation
- The base pay range for this position is $183,000 - $260,000 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
- Closely partner with Discovery to evolve translational ADME strategies and collaborate on roll-out, education and execution to ensure deep integration of knowledge from Discovery to Development
- Comply with company health and safety policies and general laboratory practices.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.