Global Development Lead Senior Director
Pfizer
Global Development Lead Senior Director
Pfizer
Makes cancer drugs, vaccines and other medicines
RoleSummary
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
BASICQUALIFICATIONS
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.
CompetencyRequirements
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 withpeers,developandcoachothers,overseeandguidetheworkofothercolleaguestoachievemeaningfuloutcomesandcreatebusinessimpact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENTREQUIREMENTS
Up to 30%travelmay berequired.
Relocationsupportavailable
WorkLocationAssignment:Thisisahybridrolerequiringyoutolivewithincommutingdistanceandworkon-siteanaverageof2.5 days per week.
#LI-PFE

The annual base salary for this position ranges from $274,500.00 to $457,500.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

* The annual base salary for this position in Tampa, FL ranges from $228,700.00 to $381,100.00.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.


Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Medical
Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.
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