Role Summary
The Global Development Lead (GDL)representsClinical on the Global Medicine Team and is the single clinical point of accountability for clinicaldevelopmentforassignedasset(s)inInternalMedicine,Research&Development,Pfizer.Theindividualwillleadthecross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues in the design,executionand 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.TheGDLisakeypartnerforotherclinicalandclinicaloperationscolleaguesthroughthelifestyleofallstudiesfortheassigned 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 responsibilitiesfortrialdesign,executionandreportingofclinicaltrialsforotherlate-stageassetsintheportfolio.Inaddition,thisleader:
- May provide specialized monitoring support ifrequired
- Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE,SCSand clinicaloverview.
- Insupportofassignedprojects,provideinputfortargetproductprofile(s),andregulatoryactivitiesincludingproductlabels,coredata sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.
Responsibilities
- PartnerseffectivelywiththeMedicineTeamLeadtonegotiatetradeoffs,milestonesandensuredeliveryoftheclinicalprograminline with agreed timelines and budget.
- Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) alongwithcreatingthepediatricinvestigationplan/pediatricstudyplanandassociatedprotocoldesigndocumentsworkingcloselywith individual trial clinicians to ensure trial feasibility andoptimizedoperational execution.
- Provides product/program specific input for target productprofile(s).
- Willingness to bring innovative thinking and bold decision making across clinical development programs and individualstudies.
- Develops specific clinical development enabling strategies including digital/ innovation and patient engagementapproaches.
- PartnerswithTrialcliniciansongovernancereviews(inclSci/Ops)forassignedclinicalstudies.Providescategoryclinicaldevelopment strategy input and insights to trial clinicians for assigned clinical studies.
- Providestherapyarea/indicationexpertiseinsupportofclinicalreviewofclinicaldata–includingCRFdesign,assistanceinsignal interpretation, contextualizing adverse events asrequired.
- Provides specialized medical monitoring support for individual trial team, ifrequired
- Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics andprograming
- Developssubmissionleveldeliverables(IAP,IARPandsubmissionTLFs).ResponsibleforsubmissiondeliverablesincludingSCEandSCS
- Supportappropriate interpretationand communication of clinical trialdata.
- Review and approve submission level safety narrativeplan.
- Supports product label development andmaintenance.
- Engagekeyexternalstakeholderse.g.,Adboards,SteeringCommittees,DMC,AdjudicationCommittees,patientsandpatientadvocates 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 productdefense.
- Ensurescompliance with internal SOPs and external regulatorystandards.
- Review IIRproposals
BASIC QUALIFICATIONS
Education
MD or DO
Experience
- Cardiologist (strongly preferred)with cardiovascular outcome trials or large complex, global development programs.
- 8+yearsofrelevantexperienceandtrackrecordofsuccessinacademiaand/orthebiopharmaceuticalindustryinclinicalresearchanddevelopment
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse eventmanagement
- Demonstratedclinical/medical,administrative,andprojectmanagementcapabilities,aswellaseffectiveverbalandwritten communication skills in relating to individuals both inside and outside Pfizer.
- Demonstrated experience managing and training large teams in clinicaldevelopment.
- Demonstrated experience in designing and launching large teamspreferred.
Competency Requirements
- Medical/Scientificcredibility/Excellence-Trackrecordofachievementinpharmaceuticaldevelopment,abletocoordinateandexecute 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 ina highly complexmatrixed environment and able to influence cross-functionalTeams.
- Leadership - Persuasive and effective leader ofstaff
- Influencing - Able to manage and motivate internal teams on clinicaltrials.
- Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them asopportunities;readssituationsquickly;canhammerouttoughagreementsandsettledisputesequitably;preparedtotakeresponsibility for a decision made and support this, even though it may be unpopular.
- TeamBuilding-Shareswinsandsuccess;fostersopendialogue;letspeoplefinishandberesponsiblefortheirwork;definessuccessin 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 deliverresults.
- Changeagile-Abletodemonstrateperspectiveandpoiseinthefaceofuncertaintyandeffectivelygetthingsdoneamidstorganizationalchange.
- Candidatedemonstratesa breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers,developandcoachothers,overseeandguidetheworkofothercolleaguestoachievemeaningfuloutcomesandcreatebusinessimpact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to 30%travelmay berequired.
Relocationsupportavailable
WorkLocationAssignment:This isahybridrolerequiringyoutolivewithincommutingdistanceandworkon-siteanaverageof2.5 days per week.
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