Jobs · Healthcare · Pennsylvania

Global Clinical Lead- Hematology

BioSpace · King of Prussia, PA · 2 days ago
HealthcareFull-time
Reporting to theHead, GlobalClinical Developmentthe Global Clinical Lead(GCL)will act in a key leadership role in theClinicalDevelopment(CD)group; Providing strategic and tacticalMedical& Scientificleadership and guidance for clinical development activities for 5-8Global Clinical Program Leaders (GCPL)Serving as the CDrepresentative on theTherapeutic Area Leadership team (TALT)forCVRTAMayact 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 5-8GCPLsWorks withother GCLsand head of clinical to ensure adequate resourcing across the portfolioManages 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 TAContributing to BD strategy & due diligence for TA &identifiesand evaluates NPO’sEnsuringhigh quality clinical & scientific content is providedintoRegulatory submissions & ensures defense and negotiation with Regulatory agenciesPreparingfor stage-gate evaluations and benefit–risk evaluations and assessmentsOverseeingand 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 deliverablesEnsuringthat the patient and physician voice is at the forefront in strategy developmentBuildingnetworks with external expertsDrivingexcellence in clinical development executionPartneringwith TA core, extended core & functional partners to ensure scientific & medically robust clinicaldev & med affairs activitiesEnhancingthe reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TARepresentingthe Co & TA externally with KOL, HealthTechnologyand external authorities at key forumsEnsuring effective presentationsat Scientific andTechnicalReviewCommitteeRepresentingthe 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.Clinical development experience leading a therapeutic area or complex clinical program with aworking knowledge of pharmaceutical and regulatory development processes is essentialA minimum of8-10years’experience preferred,acquiredin either industry or academic positions,although the latter would also require experience in working with industry sponsorsOutstanding influencing ability & collaboration skillsProven leadership experienceAbility to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularlydemonstratedability to work across the critical interfaces between Clinical andnon-ClinicalfunctionsExperience interacting with Health Authorities and designing programs that meet the needs of HA’s,commercialand payers About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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