The Global Clinical Lead (GCL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for late-stage development programs/indications. The individual is responsible for the clinical strategy and high quality, timely delivery of interventional clinical studies for an assigned medicine/program in Internal Medicine, Global Product Development. This specific role will support and provide Clinical leadership on the oral GLP-1 type 2 diabetes program, consisting of pivotal glycemic studies and a cardiovascular outcome trial. Key deliverables include design of the global Phase 3 program, oversight of Phase 3 execution, and leading global regulatory interactions and eventual submissions for the type 2 diabetes program. The individual will work closely with the GCL for the oral GLP-1 weight management program ensuring the oral GLP-1 asset can provide meaningful clinical benefit to patient care. This position reports to the Medicine Team Lead for Business Development and E2E Planning.
For the type 2 diabetes/cardiovascular risk reduction indications, the individual will lead the cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety and operations colleagues in the design, execution and interpretation of studies in support of worldwide regulatory submissions. The individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents in support of assigned indications.
The GCL is a key partner for other clinical and clinical operations colleagues through the study lifecycle. The individual is an internal subject matter expert in their therapeutic area and in clinical drug development. The GCL will work collaboratively with the GCL for the weight management indication to create a streamlined and efficient clinical development program.
S/He may assume responsibility for other clinical leadership in support of the Internal Medicine portfolio. This may include responsibilities for study design, execution and reporting for late-stage assets in the portfolio. S/He may provide specialized monitoring support if required. Where needed, S/He will lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview. In support of assigned projects S/He provides input for target product profile(s), and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports.
Partners effectively with the Medicine Team Lead for oral GLP-1 to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
Creates and obtains endorsement for the CDP in support of assigned indications and in collaboration with the GCL for the weight management program.
Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the PIP/PSP and associated protocol design documents (PDD’s) working closely with Category Clinicians as well as CD&O clinicians to ensure study feasibility and optimized operational execution.
Provides product/program specific input for target product profile(s)
Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies.
Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches.
Partners with CD&O clinician on governance reviews (incl Sci/Ops) for assigned clinical studies. Provides category clinical development strategy input and insights to CD&O clinicians for assigned clinical studies.
Provides therapy area / indication expertise in support of CD&O clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events as required.
Provides specialized medical monitoring support for study team, if required
Key partner in study level SAP, TLFs, BDRs in partnership with statistics and programing
Develops submission level deliverables (IAP, IARP and submission TLFs). Responsible for submission deliverables including SCE and SCS
Support appropriate interpretation and communication of clinical trial data.
Review and approve submission level safety narrative plan
Supports product label development and maintenance
Engage key external stakeholders e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development.
Provides regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense.
Ensures compliance with internal SOPs and external regulatory standards
Review IIR proposals
“Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.”
Cardiologist, endocrinologist, nephrologist with drug development experience across all Phases of development. Experience with cardiovascular outcome trials or large complex, global development programs
10+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development
Experience in working with external academic leadership groups in the design and execution of Phase 3 trials
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management and experience in global regulatory submissions
Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
Demonstrated experience managing and training large teams in clinical development
Demonstrated experience in designing and launching large teams preferred
Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
Management experience - Able to work in a highly complex matrixed environment and able to influence cross-functional teams.
Leadership - Persuasive and effective leader of staff
Influencing - Able to manage and motivate internal teams in clinical trials
Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular
Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team
Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results
Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change
Global travel may be required.
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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