Pfizer Clinical Group Head, Rare Disease, Early Clinical Development ( MD in Cambridge, Massachusetts
The overall role of the Early Clinical Development (ECD) Clinical Group Head role 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 Rare Disease.
The ECD Clinical Group Head will be responsible for leading a team of clinicians (5-10 individuals both medically and non-medically qualified individuals) including participating as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. The ECD Clinical Group Head will be the primary liaison for a given therapeutic area to ensure clinical teams are adequately resourced and also 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 results
Supports clinical strategy development and execution for all post-FIH programs through proof of mechanism and proof-of concept
Develop and retain an outstanding ECD clinical research team, in a given therapeutic area, to deliver the clinical portfolio in an innovative, compliant and cost effective manner (manage, support and maintain a team of 5-10 clinicians)
Participate in optimizing the preclinical-to clinical POC portfolio in collaboration with the RU in scope
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
Provide discipline expertise in the evaluation of external collaboration and acquisition opportunities as needed, including due diligence activities
Sit on project teams from FIH/POM/ESoE through POC trial completion to support clinical development strategies, 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.
Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
Expand the culture of collaboration 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.
Requires MD or MD/PhD, (relevant experience in Rare Diseases preferred)
Deep understanding of the biopharmaceutical environment and the drug development
10-15 years of relevant experience in drug development with proven track record executing development programs to completion or targeted milestone
Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management
Experience in leading of a group of clinicians involved in early drug development
A clear working knowledge of the clinical development process
Demonstrated ability to support the formulation and execution of clinical strategies; Experience in generating hypothesis driven research investigations
Biopharmaceutical 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.
Results-oriented with demonstrated track record of success in clinical development
Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography
Entrepreneurial mindset with the ability to bring creative solutions to challenges
Ability to think and frame problems strategically
Quick action taker, able to involve the right team members in the right situation at the right time with a fit for purpose attitude
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.
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Additional Offer Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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.