Pfizer Vice President, Head of Oncology Clinical Pharmacology in San Diego, California
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This senior executive is responsible for ensuring appropriate Clinical Pharmacology representation on drug development and clinical teams, and provision of clinical pharmacology expertise and leadership to projects across various oncology therapeutic modalities (including small molecules, mAbs, ADCs, bispecifics, vaccine-based immunotherapy regimen and CARTs), and various tumor types. . S/He will be responsible for ensuring planning and direction of clinical pharmacology components of clinical programs (including clinical development plan) and studies (including outline and core element preparation; clinical phase oversight, reporting) including the use of quantitative analytical methods to integrate knowledge of PK, PD, patient and disease characteristics to optimize doses, ensure appropriate summarization and interpretation of the results of PK/PD analyses with respect to their impact on drug development, and ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration in First in Patient studies. The Clinical Pharmacology Head supervises Clinical Pharmacology Leads who are collectively responsible for the leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies including partnership with Clinical, Translational Oncology and Statistics to drive quantitative clinical development strategies. S/He will be a champion for early clinical development needs and approaches within the research unit and associated platform lines, and will maintain organizational focus on the effort through visible, active involvement in clinical programs. S/He will provide clinical pharmacology expertise and leadership supporting various regulatory interactions, and scientific publications/presentations to the medical communities
S/He will be a member of the Early Oncology Development and Clinical Research Leadership Team responsible for:
• delivering increased numbers of high value potential medicines that work through better selection and validation of targets and innovative clinical programs that minimize cost and time to a positive Proof of Concept
• promote a value driven culture: organizational focus on value creation and driving accountability
• have an entrepreneurial mindset: appropriate tolerance for risk tempered by an awareness of cost and time to know
• deliver great science: pursue the right targets, with molecules that survive, executed swiftly
S/He will also serve as a member of the Global Clinical Pharmacology Leadership Team responsible for:
• promoting Clinical Pharmacology excellence across Pfizer
• championing Clinical Pharmacology influence
• Accountable for Clinical Pharmacology input and execution from candidate selection to Proof of Concept (POC).
• Responsible for optimal resource deployment across projects.
• Leads group of clinical pharmacology resources who are dedicated to meeting project needs including: developing efficient early clinical plan including translational PK-PD strategy and designing, analyzing, interpreting and supporting execution of Phase 1, 2a studies consistent with best practices.
• Recruit, train, develop, mentor and retain highly skilled clinical pharmacologists to provide effective and qualified resources to support the objectives of the Research Units and Early Oncology Development and Clinical Research.
• Ensures knowledge transfer to Global Product Development at Proof of Concept including models to inform Phase 2b/3 strategy
• Clinical Pharmacology Head may also be responsible for suitability of bioanalytical methods for PK characterization and immunogenicity response profiling (anti-drug antibodies and neutralizing antibodies) with respect to the given study objectives as well as the overall asset development strategy.
• Partners with platform support such as Pharmacometrics and Clinical Assay Group.
• Partners with Clinical Lead to ensure Early Signs of Efficacy (ESOE), Enhanced Quantitative Drug Development (EQDD), and Enhanced Clinical Trial Design (ECTD) approaches are optimized for deployment.
• Partners with Pharmacokinetics, Dynamics and Metabolism (PDM) to ensure optimal transition from pre-clinical models to the clinic, and ensure that, if applicable, appropriate bioanalytical assays are developed and validated timely for clinical use.
• Responsible for Clinical Pharmacology input into Pre Proof of Concept licensing and development.
• Core member of the Global Clinical Pharmacology Leadership Team.
• Works effectively with the Global Head of Clinical Pharmacology and the Global Clinical Pharmacology Leadership Team in formulating the vision, mission, standards and best practices for clinical pharmacology at Pfizer.
• Education: Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology, or related discipline.
• Experience: 10 or more years in the industry working in pharmacokinetics, pharmacometrics, clinical pharmacology, or related discipline.
• Clinical pharmacology: demonstrates thorough understanding of the following: 1) principles of PK, PK-PD (mechanistic modeling is essential) and oncology therapeutics; 2) knowledge and experience in applying principles of PK, PK-PD across to various oncology therapeutic modalities and tumor types. 3) knowledge of oncology early development studies (including study design, conduct and data interpretation); and 4) other relevant scientific disciplines, such as drug metabolism, drug transporter, formulation sciences, biopharmaceutics for small molecular drugs, and detection and analysis of immunogenicity response and the impact on PK, safety and/or efficacy for biologics.
• Communication Skills: demonstrates ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
• Scientific Excellence: demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for early oncology development.
• Regulatory Knowledge: understands and is able to apply appropriate Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH) guidelines in the design of clinical development plans and studies.
• Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of development objectives.
• Big Picture/Strategic Thinking: ability to demonstrate a broad perspective on the overall asset development and how clinical pharmacology contributes; ability to understand all stakeholder needs.
• Innovation: constantly looking for new approaches and able to devise/apply new techniques in clinical pharmacology.
• Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the development of drug candidates.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.