Global Clinical Lead - Hematology

Entity: CSL Behring Job Category: Research Development & Sciences Job Family: Research Development & Sciences Multi Discipline Job Type: Full Time Location**:** Waltham, Massachusetts, United States Employer Reference: R-288291 Job Description Reporting to the Head, Global Clinical Development the Global Clinical Lead (GCL) will act in a key leadership role in the Clinical Development (CD) group; Providing strategic and tactical Medical & Scientific leadership and guidance for clinical development activities for 5-8 Global Clinical Program Leaders (GCPL)Serving as the CD representative on the Therapeutic Area Leadership team (TALT) for CVR TAMay act as any of the following roles in clinical development: GCPL, Early Clinical Development Lead, Business Development (BD) Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead as appropriate for projects as assigned per business need Main Responsibilities and Accountabilities: GCL Line Manager Responsibilities Include Providing strategic and tactical medical leadership and guidance for clinical development activities in for 5-8 GCPLsWorks with other GCLs and head of clinical to ensure adequate resourcing across the portfolioManages team of clinical drug developers, acts as a mentor to physician group in guide clinical development expertise in general and in specific areas of therapeutic knowledge GCLTALTCDRepresentativeresponsibilitiesinclude**:**Defining the global clinical development strategy for all projects in TAContributing to BD strategy & due diligence for TA & identifies and evaluates NPO’sEnsuring high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agenciesPreparing for stage-gate evaluations and benefit –risk evaluations and assessmentsOverseeing and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global Project Leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal Project strategy GCL Other Responsibilities Include Be an active member of the Clinical Development Leadership Team, improving the overall quality of the group and its deliverablesEnsuring that the patient and physician voice is at the forefront in strategy developmentBuilding networks with external expertsDriving excellence in clinical development executionPartnering with TA core, extended core & functional partners to ensure scientific & medically robust clinical dev & med affairs activitiesEnhancing the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TARepresenting the Co & TA externally with KOL, Health Technology and external authorities at key forumsEnsuring effective presentations at Scientific and Technical Review CommitteeRepresenting the clinical function on the TALT, responsible for input into TALT strategy, oversee the quality of clinical plans in the CVR TA. 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 TA is a must.Clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is essentialA minimum of 8-10 years’ experience preferred, acquired in 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; particularly demonstrated ability to work across the critical interfaces between Clinical and non-Clinical functionsExperience interacting with Health Authorities and designing programs that meet the needs of HA’s, commercial and 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.