Global Development Lead, Internal Medicine

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role  Summary  

The Global Development Lead (GDL)  represents   Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical   development   for   assigned   asset(s)   in   Internal   Medicine,   Research   &   Development,   Pfizer.   The   individual   will   lead   the   cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, 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   GDL   is   a   key   partner   for   other   clinical   and   clinical   operations   colleagues   through   the   lifestyle   of   all   studies   for   the   assigned asset(s). The GDL may also act as a key partner to external companies in support of Pfizer's Partner of Choice model. The individual is expected to be an internal subject matter expert in their therapeutic area and in clinical drug development.  

They may assume responsibility for other clinical leadership opportunities in support of the Obesity portfolio. This may include responsibilities   for   trial   design,   execution   and   reporting   of   clinical   trials   for   other   late-stage   assets   in   the   portfolio.   In   addition,   this   leader:  

• May provide specialized monitoring support if  required  

• Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE,  SCS   and clinical  overview.  

• In   support   of   assigned   projects,   provide   input   for   target   product   profile(s),   and   regulatory   activities   including   product   labels,   core   data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.  

Responsibilities  

• 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.  

• Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along   with   creating   the   pediatric   investigation   plan   /   pediatric   study   plan   and   associated   protocol   design   documents   working   closely   with individual trial clinicians to ensure trial 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   Trial   clinicians   on   governance   reviews   (incl   Sci/Ops)   for   assigned   clinical   studies.   Provides   category   clinical   development strategy input and insights to trial clinicians for assigned clinical studies.  

• Provides   therapy   area/ indication   expertise   in   support   of   clinical   review   of   clinical   data   -   including   CRF   design,   assistance   in   signal interpretation, contextualizing adverse events as  required .  

• Provides specialized medical monitoring support for individual trial team, if  required  

• Key partner in trial-level statistical analysis plan, table-listings-figures, database release 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  p