Clinical Pharmacology Leads at Pfizer are key members of multidisciplinary drug development project teams who provide subject matter expertise in quantitative pharmacology and are uniquely positioned to work at a technical level while having the opportunity to influence drug development strategy within the organization. Working closely with colleagues across research and development, Clinical Pharmacology Leads apply their technical expertise to analyze, develop, validate, and implement quantitative models to inform key drug development decisions. They are also responsible for design, conduct, oversight and reporting of clinical pharmacology components of clinical programs and studies.
We are seeking to hire a Clinical Pharmacology Lead (Associate Director) to join the Oncology Clinical Pharmacology team within the Early Clinical Development Clinical Pharmacology group. The position can be based in San Diego, CA or Boulder, CO. The individual will be responsible for independently developing and implementing the Clinical Pharmacology Plan and Modeling-Informed Drug Development (MIDD) strategy for early oncology programs, using state-of-the-art quantitative methodologies to integrate knowledge of cancer biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and disease-progression. The ideal candidate will have prior industry experience in clinical pharmacology with expertise in PK/PD modeling.ROLE RESPONSIBILITIES
- Independently develop the clinical pharmacology and MIDD plans for early oncology drug development programs, including both small and large molecules.
- Oversee clinical pharmacology investigations on multidisciplinary program teams and work closely with clinicians, biostatisticians, translational oncology and clinical operations colleagues to design, conduct and report clinical trials from first-in-patient to proof-of-concept; be responsible for clinical pharmacology components of early oncology programs, including PK, PK/PD, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).
- Collaborate with preclinical scientists and analyze translational models developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.
- Lead the scientific justification for optimal human starting dose and dose escalation schemes for oncology first-in-patient protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.
- Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for clinical studies.
- Conduct PK data analysis and develop computational models from PK/PD, safety and efficacy data collected in early stage clinical trials; provide clinical pharmacology guidance on program decision-making.
- Lead the clinical pharmacology contributions to regulatory and clinical documents including IND, CTA, investigator brochures, clinical development plans, protocols, and study reports.
- Lead the resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries.
- Present clinical pharmacology results to internal and external stakeholders; author scientific publications.
- Align with global clinical pharmacology groups at Pfizer to maintain consistency with best practices and ensure the state-of-the-art quantitative approaches are being applied to inform key drug development decisions.
- Advanced degree (Ph.D., Pharm.D.) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
- 4-6 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.
- Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R, NONMEM)
- Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
- Excellent verbal and written communication skills.
- Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
OTHER JOB DETAILS
- Prior experience serving as a clinical pharmacology lead in an oncology drug development setting is desirable .
- Demonstrated leadership experience and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
For roles based in Colorado: The annual base salary for this position ranges from $122,500.00 to $204,000.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Relocation assistance may be available based on business needs and/or eligibility.
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