Clinical Pharmacology Lead Job in Cambridge, Massachusetts US
Clinical Pharmacology Lead
Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Responsibilities Apply Systems Pharmacology utilizing systems biology approaches, while combining experimental studies with model-based computational analyses to study drug activities, targets and effects. Work within a drug discovery and early clinical development environment to develop a mechanistic model which captures and describes the dynamic relationships in neurological (or other) disorders. Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as appropriate. Participate in a TRIAD setting including statistical and clinical/medical experts. Participate in implementing Model Based Drug Development (MBDD) using quantitative approaches to address complex questions arising during drug development. Work in an applied setting to explore the application and nuances of various trial designs, choice and sensitivity of endpoints. Required to work closely with other modellers/statisticians as well as clinicians. Will be responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team. Will develop an intimate understanding of the overall clinical development plan and works closely with the Clinical and Development Team to continually update and refine plan. Plans, designs and oversees clinical pharmacology studies as required throughout all stages of drug development with operational assistance from Clinical Research Operations. Participates with medical writers (and other team members) in the data review, analysis and reporting of the CP study. Be responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators, etc. Be a coach and mentor for the clinical study team for the specifics of the protocol and therapeutic area in which it is being conducted. Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis, mechanistic modeling, quantitative systems pharmacology modeling etc. Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant). Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation such as labeling. Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings and NDA/MAA. Will lead in the resolution of clinical pharmacology queries from drug regulatory agencies, and writing and reviewing responses to regulatory queries. Provides Clinical Pharmacology expertise to Discovery as appropriate. During the preclinical stages of drug development, works with Research to ensure that sufficient preclinical PK-PD and quantitative systems pharmacology modeling knowledge exist to underwrite safe human administration. Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic. Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology knowledge in terms of clinical trial design. May represent group on company initiative sub-teams. May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management. May act as CL for specific drug development projects as agreed with line management Ability to produce and present quality scientific papers at external meetings and for publication. With line management endorsement, manage and initiate external collaborations with world leading clinical pharmacology experts to develop new methodologies. Qualifications 0-4 years of industry experience. Excellent written and verbal communication skills. Demonstrated presentation skills. Knowledge of biological systems. Ability to quantify biological systems, processes and mechanisms. Abilty to quantify physiological systems and processes. Knowledge of neural networks and circuitry is desired. Familiar with non-linear mixed effects modeling software (NONMEM, etc.), computational modeling software (SBML), statistical software (R, S+, etc.) are desired. Systems modeling knowledge and experience with other modeling software (Matlab, Berkeley Madonna, etc.) is highly desired. Modeling/bioengineering experience is desired. Education: PhD in Bioengineering, Applied Statistics, Mathematics or Pharmacometrics Equal Employment Opportunity 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with