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.
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.
