Clinical Pharmacology Quantitative Scientist / HYBRID REMOTE
San Francisco, CA
Base Salary 185-225K+ Annual Incentive Opportunity+ Commission + Full Benefits + Stock Options. Also Includes Executive Benefits Package: Medical, Rx, Dental, Disability, Life Insurance, Flexible Spending Accounts, Retirement Savings Plans with Company Match/Contributions, Education Assistance, Bonus Plan Eligibility, Parental Leave
The Clinical Pharmacology (CP) Scientist is responsible for developing and implementing quantitative Clinical Pharmacology strategies across early to late phases of clinical drug development to ensure that the right drug is administered to the right patient at the right dosing regimen and to deliver an optimal therapeutic benefit/risk profile for the patients. The CP Scientist uses state of the art modeling and simulation tools and is able to implement model-informed drug development strategies to address critical questions that are aligned with project needs. The CP Scientist is an active member of cross-functional drug development teams, and works in close partnership with Pharmacometricians, Biostatisticians, Clinicians, Biomarker Scientists, Toxicologists, Preclinical Pharmacologists, and other function) to support drug development decisions through registration and post-marketing commitments.
A Senior/Principal (Sr/Pr) CP Scientist represents CP function on global filing teams and fosters effective collaboration and communications with regulatory agencies to support efficient drug development of drug candidates. A Sr/Pr CP Scientist serves as a senior member of the scientist family and a mentor to junior scientists. A Sr/Pr CP Scientist fosters effective scientific collaborations and synergy and helps drive the scientific direction and platform initiatives for developing novel immune-oncology agents in disease areas with high unmet needs.
- Leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols, analysis and interpretation of PK/PD data, preparation and review of regulatory documents, presentation of results at different forums (cross-functional teams, department meetings, governance meetings, conferences, etc.).
- Candidates will also represent Clinical Pharmacology in health authority/regulatory meetings (e.g. End of Phase 2, pre-BLA/NDA, etc.), and contribute to the planning, implementation and organization of regulatory filings (e.g. IND, BLA, NDA, sNDA).
- Familiarity with clinical study design, protocol authorship. The ability to plan, organize, and interpret, assess and/or perform PK/PD data analyses is required.
- Working knowledge of statistical and modeling and simulations approaches as they apply to clinical study design & analysis.
- Working knowledge of immunology and/or immune-oncology drug development is highly desired.
- Experience in leading global regulatory filing strategy as a CP lead to support the totality of CP filing package, dose/regimen justification, and drug labeling in highly desired.
-Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (e.g. NONMEM, R, SimBiology, WinNonlin, SimCYP, GastroPlus) is desired.
- Excellent written communication skills, in order to deliver high quality protocols, publications, and regulatory documents for team and management review.
- Excellent oral communications to make clear presentations and foster effective stakeholder engagement.
- Strong leadership and interpersonal skills and the ability to influence are highly desired.
Drug Development Knowledge:
- The CP Scientist requires relevant experience/knowledge of how CP science can impact drug development
- CP Scientist should have a good knowledge of GCP and working knowledge of relevant regulatory guidelines.
- Experience in leading drug development cross-functional teams is required.
- Experience in supervisory, mentoring, and/or management roles is highly desired. mBased on experience and ability, the CP Scientist
- Experience in leading scientific initiatives (internal and external scientific leadership) is highly desired.
- PhD, PharmD, MD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, or related quantitative discipline
- 5+ years of clinical drug development experiences
- Strong track record of publications and external presentations is preferred