Associate Scientific Director, Clinical Pharmacology
Biogen
Principal Scientist, Clinical Pharmacology, Modeling & Simulation
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: South San Francisco • California • 🇺🇸 United States
Visit company websiteSalary
💰 $162,988 - $192,921 per year
Job Level
Lead
About the role
- Drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs
- Act as Subject Matter Expert applying Quantitative Translational and Clinical Pharmacology approaches (PK/PD, M-PBPK, M-PBPK-PD, QSP) integrated with emerging Machine Learning and Generative AI approaches
- Guide optimal clinical drug development across therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease
- Apply modeling across diverse modalities from small molecules and mAbs to novel modalities
- Inform clinical study designs, optimal dosage selection in target patient populations, and characterization of drug-drug interactions
- Lead design and implementation of clinical pharmacology and biopharmaceutic studies (bioequivalence, bio-comparability, DDI, special populations, ethnic sensitivity, ADME, pediatric)
- Interact with global health authorities, author regulatory documents, and contribute to global regulatory filings and product labels
- Collaborate with cross-functional teams to integrate modeling results into clinical development decision-making
Requirements
- Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience OR Master’s degree and 4 years OR Bachelor’s degree and 6 years OR Associate’s degree and 10 years OR High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience
- PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering) or equivalent professional degrees (MD, PharmD) preferred
- 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry (preferred)
- Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling
- Experience to inform clinical study designs, optimal dosage selection, characterization of drug-drug interactions, dosing in special populations, ethnic sensitivity, pediatric and biopharmaceutics studies
- Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling
- Established track-record of Model Based Drug Development (MIDD)
- Established track-record of interaction with global health authorities, authoring regulatory documents, and knowledge of global regulatory requirements and guidance
- Experience in leading design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies
- Ability to integrate study results into regulatory filings and product labels
- Familiarity with emerging Machine Learning and Generative AI approaches integrated with modeling (implied/desired)
Benefits
- Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
- Financial plans with opportunities to save towards retirement or other goals
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program (or sales-based incentive plan for field sales representatives)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements
- Work/life balance and career development opportunities
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical PharmacologyModeling & SimulationPK/PD modelingM-PBPK modelingM-PBPK-PD modelingQSP modelingBioequivalence studiesBio-comparability studiesDrug-drug interaction studiesADME studies
Soft skills
LeadershipCollaborationCommunicationInterpersonal skillsDecision-making
Certifications
PhD in PharmacokineticsPhD in Pharmaceutical SciencesPhD in PharmacologyPhD in Chemical EngineeringMDPharmD
