JOB SUMMARY
The Associate Director/Director will be responsible for designing and executing clinical pharmacology strategy for oncology small-molecule programs, including PK/PD study design, dose selection and optimization, and the use of modeling and simulation approaches (e.g., PBPK, population PK) to inform program decisions. This role partners closely with Clinical Development, DMPK, Biostatistics, and Regulatory Affairs to author and review protocols and clinical pharmacology sections of regulatory submissions (IND/IMPD, briefing documents, and CTD modules) and to prepare responses to health authority queries. The role also contributes to drug-drug interaction, organ impairment, and cardiac safety (QT) assessment strategies for small-molecule oncology assets, ensuring alignment with current FDA/EMA/ICH guidance (including ICH M12), and may mentor junior scientists within the function.
KEY RESPONSIBILITIES
- Represent Clinical Pharmacology line function and work on multi-disciplinary oncology small-molecule program teams (clinical, DMPK, regulatory, biometrics, CMC, etc.), supporting programs from late-stage discovery and IND-enabling activities through Phase 1 dose escalation/expansion and beyond.
- Independently analyze, interpret and report clinical PK, PK/PD, and exposure-response data for oncology small-molecule assets as a member of multidisciplinary development program teams.
- Partner with Clinical Development to design clinical pharmacology components of oncology studies, including first-in-human dose escalation/expansion, drug-drug interaction, hepatic/renal impairment, food-effect, and cardiac safety (ECG/QT) studies, and combination-therapy dosing strategies.
- Apply quantitative approaches (e.g., PBPK, population PK, exposure-response modeling) to inform dose selection and DDI risk assessment, with working knowledge of relevant software (e.g., SimCyp, Phoenix WinNonlin, NONMEM, R) and current regulatory frameworks (e.g., ICH M12, FDA DDI guidance).
- Write and review relevant sections of regulatory and scientific documentation including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans and Clinical Study Reports.
- Maintain a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
- Review and author scientific publications, abstracts, posters
- Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner.
QUALIFICATIONS
- PhD or equivalent in Pharmacology/Biomedicine/Biochemistry or related scientific discipline with a minimum 5 years of relevant experience within a pharmaceutical industry, contract research, or clinical research.
- Experience with clinical development of oncology small-molecule therapeutics is highly desirable, including familiarity with dose-escalation/expansion trial designs and combination-therapy regimens.
- Proficiency using Phoenix Winnonlin for non-compartmental analysis
- Working knowledge of PBPK modeling and current DDI regulatory frameworks (e.g., ICH M12, FDA guidance) is highly desirable.
- Hands on clinical pharmacology related work experience in regulatory and scientific documentation writing including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports, as well as regulatory documents.
- Familiarity with PK bioanalytical methods development and validation is an asset
- Ability to manage multiple projects, prioritize work effectively to meet deadlines, anticipate potential problems within project plans and effectively communicate alternatives.
- Strong communication skills, with the ability to work collaboratively as a member of a cross-functional team.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
