Reporting to theHead, GlobalClinical Development the Global Clinical Lead(GCL)will act in a key leadership role in theClinicalDevelopment(CD)group;
Mayact as any of the following roles in clinical development:GCPL, Early Clinical Development Lead, BusinessDevelopment (BD)Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Leadas appropriate forprojects asassigned per business need
Main Responsibilities and Accountabilities:
GCL Line Manager responsibilities include:
- Providing strategic and tactical medical leadership and guidance for clinical developmentactivities infor 5-8GCPLs
- Works withother GCLsand head of clinical to ensure adequate resourcing across the portfolio
- Manages team ofclinical drug developers, acts as a mentor to physician group in guide clinical developmentexpertisein general and in specific areas of therapeutic knowledge
GCLTALTCDRepresentativeresponsibilitiesinclude:
- Definingtheglobal clinical development strategy for all projects in TA
- Contributing to BD strategy & due diligence for TA &identifiesand evaluates NPO’s
- Ensuringhigh quality clinical & scientific content is providedintoRegulatory submissions & ensures defense and negotiation with Regulatory agencies
- Preparingfor stage-gate evaluations and benefit–risk evaluations and assessments
- Overseeingand supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and GlobalProjectLeaders toensureoptimalclinical strategy,CDPandprotocol design to supportoptimalProject strategy
GCL Other Responsibilities include:
- Be an active member of the Clinical Development Leadership Team, improving the overall qualityof the group and its deliverables
- Ensuringthat the patient and physician voice is at the forefront in strategy development
- Buildingnetworks with external experts
- Drivingexcellence in clinical development execution
- Partneringwith TA core, extended core & functional partners to ensure scientific & medically robust clinicaldev & med affairs activities
- Enhancingthe reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA
- Representingthe Co & TA externally with KOL, HealthTechnologyand external authorities at key forums
- Ensuring effective presentationsat Scientific andTechnicalReviewCommittee
- Representingthe clinical function on the TALT, responsible for input intoTALTstrategy,overseethe quality of clinical plans in theCVRTA.
Position Qualifications and Experience Requirements:
- MD, Board Certified (or non-USA equivalent) with relevant sub-specialty highly preferred- if not Board Certified in relevant Subspecialty, then experience in that TAisa must.
