OverviewCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.The incumbent will be responsible for the quality and delivery of high-quality clinical development documents and oversight of clinical study delivery across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Serve as the decision support lead for the SVP Portfolio Development (PD) and ensure excellence throughout the Portfolio Development organization.ResponsibilitiesOversight of IndividualsRecruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approachesEnsuring delivery of high-quality clinical development content includingClinical development plans, protocols, study reports, common technical document modules and publications in academic journalsRegulatory submissions and meetingsStage-gate and benefit –risk evaluations and assessmentsPresentations at scientific and technical review committeesImplementation of clinical recommendations from all advisory and governance committeesInternal interfaces and collaborationOversight of and collaboration with partnering functions, e.g. Research, GRA & Safety, POE, TES, CROs and Medical Writing VendorsEffecting extensive and collaborative dialogue with TA co-leads to optimize project strategyWorking with Head Clinical Operations to ensure appropriate resourcing to support TA activities and to ensure project planning and execution is aligned with TA PrioritiesMaintaining effective oversight of quality in conjunction with appropriate Quality functionsExternal-scientificEnhancing the reputation of the Company through a culture of scientific integration of the department with academia and other partners through visible publication record, KOL Interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific expertsEnsures that the patient and physician voice is at the forefront in TA strategy developmentBuilding a culture of risk taking, innovation and peer review across the clinical functionProviding clinical scientific leadership throughout CSLProviding support and insight into business development opportunities as requiredQualifications & Experience RequirementsExperience across all phases of development, FIH, POC, late-stage development and life cycle managementStrong track record of oversight of successful drug development programsExperience across a wide range of regulatory interactions e.g. filings, Ad coms etc10yrs+ of pharma experience in clinical developmentStrong personal leadership skillsHigh level of self-awareness and the awareness of personal impactEnhanced organizational awareness and the ability to interact and influence from the team level to senior managementSuccinct and clear communication styleExtensive experience of leading teams and/or line managing a group(s)Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.About CSL BehringCSL 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.Inclusion and BelongingWe want CSL to reflect the world around us. 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. Learn more about Inclusion and Belonging at CSL.Do work that matters at CSL Behring! #J-18808-Ljbffr