The Global Clinical Lead (GCL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned assets in Internal Medicine, Global Product Development. There are two main aspects to this role. 1) The GCL will provide clinical leadership in support of global Business Development and licensing initiatives including technical due diligence and creation of clinical development plans to support global approvals and market access for assigned Business Development projects. 2) The GCL will also be accountable for End-to-End (E2E) clinical development planning for select assets in Internal Medicine with a focus on assets ahead of transition into GPD. A key deliverable is to develop E2E clinical development programs with the goal of reducing the overall development time by building fast to approval plans for early medicine candidates to enable Pfizer to make a greater impact on patient care. This position reports to the Medicine Team Lead for Business Development and E2E Planning.
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. The GCL is a key partner for other clinical and clinical operations colleagues through the study lifecycle. The GCL also acts as a key partner to external companies in support of Pfizer's Partner of Choice model. The individual is an internal subject matter expert in their therapeutic area and in clinical drug development.
S/He may assume responsibility for other clinical leadership opportunities 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. ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS "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." Education PREFERRED QUALIFICATIONS Experience
- Partners effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
- Leads clinical due diligence efforts in support of Business Development activities.
- Creates the CDP in support of Business Development activities.
- Partners with IMRU to develop an E2E clinical development plan in support of GPD and organization milestones.
- 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.
- Identifying external science opportunities for portfolio optimization
- Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches.
- Partners with Category Clinician and 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
- Cardiologist, endocrinologist, nephrologist with drug development experience across all Phases of development. Experience with cardiovascular outcome trials or large complex 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 multiple disease areas to enable support of various Business Development activities
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- 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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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
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.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel required. Last Date to Apply for Job: October 5, 2022
Eligible for Employee Referral Bonus: YES
Relocation assistance may be available based on business needs and/or eligibility.
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