https://globaljobs.pfizer.com/pages/jobs.aspx Job ID: 1011589
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place. Role Description The Clinical Pharmacology Lead serves as the Clinical Pharmacology representative on multidisciplinary development teams and provides clinical pharmacology expertise and leadership to a project. The position entails partnering with development colleagues to integrate prior knowledge in order to develop innovative clinical development strategies and study designs for Phase 1-IV clinical trials by applying the principles of model based drug development The position entails partnering with development colleagues to integrate prior knowledge in order to develop innovative clinical development strategies and study designs for Phase 1-IV clinical trials by applying the principles of model based drug development in the area of inflammation & Immunology. Clinical Pharmacology Leads work closely with clinicians and statisticians to create clinical development plans that include assessments of a drug's efficacy, safety, commercial viability and fulfillment of registration requirements. The Clinical Pharmacology Lead has primary responsibility for the clinical pharmacology components of the development plan. In order to achieve these aims, Clinical Pharmacology Leads are responsible for the use of innovative analytical methods to integrate knowledge of pharmacokinetics, biopharmaceutics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs, and to provide clinical pharmacology support and leadership in the preparation and defense of regulatory submissions. Clinical Pharmacology Leads routinely interact with internal governance bodies, regulatory agencies and external opinion leaders. They are expected and encouraged to influence the external environment by advancing their discipline through external presentations and publications. Responsibilities * Serves as the Clinical Pharmacology representative on Drug Development and Clinical Sub-Teams from post proof-of concept (POC) through loss of exclusivity and provides clinical pharmacology expertise and leadership to projects * Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to determine probability of success, optimize doses, dosage regimens and study designs throughout clinical drug development * Plans and directs clinical pharmacology components of clinical programs (including clinical development plan) and studies (including synopsis preparation; clinical phase oversight, when appropriate; reporting) * Works with multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies * Responsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients * Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon best practices (i.e. model-based drug development). * Responsible for appropriate summarization and interpretation of results of pharmacokinetic/pharmacodynamic (PK-PD) analyses, including quantitative contextualization of competitor data with respect to their impact on development and clinical use of drugs * During the pre-POC stage of drug development, collaborates with Clinical Research to ensure that principles of model-based drug development have been applied to planning for POC * Provides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions Qualifications EDUCATION AND EXPERIENCE The ideal candidates will have a doctorate degree with demonstrated expertise in clinical pharmacology and/or pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modeling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modeling, and clinical trial simulations) using NONMEM, R etc. TECHNICAL SKILLS REQUIREMENTS PK/PD modeling and simulation skills such as those listed above Excellent verbal and written communication skills PHYSICAL POSITION REQUIREMENTS This is an "office"-based job that will require the ability to travel EEO & Employment Eligibility 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. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
