Pfizer Director, Clinician (MD), Early Clinical Development (ECD) in Cambridge, Massachusetts
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.
The overall role of the Early Clinical Development (ECD) Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic areas: e.g. Immunology and Inflammation, Cardiovascular/Metabolic, Neruosciences, or Rare Disease.The ECD Clinician will participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. The ECD Clinician will work with other functional disciples to ensure the full scope and remit of ECD is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).The individual will be involved with clinical drug development activities from FIH through POC. They will be a key member and/or contact for project teams to ensure collaboration and seamless connectivity between ECD, Research Units and Global Product Development (late stage development and study operations).
Responsible for medical leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study resultsSupports execution for all post-FIH programs through proof of mechanism and proof-of conceptServe as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractorsSupport and assist in the development of publications, abstracts, and presentationsSit on project teams from FIH/POM/ESoE through POC trial completion to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.May be responsible for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.Support preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. *Collaborate between the clinical team and ECD by maintaining open communications between the two groups and ensuring successful program completion. *Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas. *Coordinate with other clinical research activities in ECD and greater World-Wide Research and Development (WRD) organization.Develop effective collaborations with key partners in Pfizer Discovery Research Units (RU) as well as Centers for Therapeutic Innovation (CTI) and Precision Medicine. Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, precision medicine and development operations. *Partner with Precision Medicine as needed to ensure that biomarker plans are enabled in all relevant therapeutic area programs to help determine early signs of efficacy and proof of concept, patient stratification, etc.Establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results. *Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
Qualifications Requires MD or MD/PhD (relevant experience in Immunology and Inflammation, Cardiovascular/Metabolic, Neurosciences, or Rare Disease preferred)Deep understanding of the biopharmaceutical environment and the drug development 3-5 years of relevant experience in drug development with proven track record executing development programs to completion or targeted milestoneStrong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior managementTechnical Skills A clear working knowledge of the clinical development processDemonstrated ability to support the formulation and execution of clinical strategies; Experience in generating hypothesis driven research investigationsBiopharmaceutical experience as a medical monitor and clinical lead for translational medicine projects across therapeutic areas is desirable. *Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.Ability to analyze and interpret complex datasets.Ability to operate with a sense of pace and urgency in matrixed project teams.Exercises initiative in meeting goals and drives innovation in projects. Demonstrated scientific productivity (publications, abstracts, etc.). *Good communication and presentation skills as well as proven scientific writing skills.Core CompetenciesResults-oriented with demonstrated track record of success in clinical developmentAbility to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geographyEntrepreneurial mindset with the ability to bring creative solutions to challengesAbility to think and frame problems strategicallyQuick action taker, able to involve the right team members in the right situation at the right time with a fit for purpose attitudeNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Occasional Travel 5-15%
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.
Director, Clinician (MD), Early Clinical Development (ECD) Cambridge, Massachusetts 1046428-1852