Global Development Lead, Internal Medicine (MD, Sr. Director)

About this role

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   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  

BASIC   QUALIFICATIONS  

Education  

MD or DO    

Experience  

• Cardiologist (strongly preferred)   with cardiovascular outcome trials or large complex, global development programs .  

• 8 +   years   of   relevant   experience   and   track   record   of   success   in   academia   and/or   the   biopharmaceutical   industry   in   clinical   research   and   development  

• 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.  

Competency   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

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