Senior Medical Director, Global Clinical Program Lead - Immunoglobulins

h3Position Overview: /h3 pThe Senior Medical Director, Global Clinical Program Leader (GCPL) is a critical role within Clinical Development. The Senior GCPL is /p paccountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrixed environment. Reports to the Global Clinical Lead (GCL). /p h3Work Environment: /h3 pb*** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation assistance and visa sponsorship are not provided. /b /p h3Key Resonsibilities: /h3 pClinical Development Team (CDT) Leadership: /p ul liProvides leadership and guidance to all members of the cross-functional CDT acting as the lead scientific expert for the clinical program, while ensuring appropriate functional representation in team discussions /li liaccountable for the timely development and maintenance of the Clinical Development Plan (CDP) in alignment with the Program Strategy Team (PST) and Therapeutic Area Leadership Team (TALT) /li liLeads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s) /li liMaintaining alignment across critical stakeholders prior to key decision making forums (e.g. Strategic Development Committee (SDC) or Scientific and Technical Review Committee (STRC) for study outline approval) /li liEnsures that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations /li liResponsible for driving and documenting decision making within the CDT, facilitating issue resolution and escalation, as well as contingency planning /li /ul pClinical Scientific Oversight: /p ul liAccountable for the clinical content for all CDT deliverables to ensure safe, efficient, timely and quality execution of assigned clinical programs /li liEnsures high quality clinical and scientific standards are met throughout all aspects of the program /li liServes as the clinical development representative on the required cross-functional teams, including but not limited to the Study Execution Team (SET), Safety Management Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy Team (EAST) for assigned programs /li liDevelops and executes the Medical Monitoring Plan (MMP) strategy /li liTypically serves as the medical monitor for clinical trials during study conduct or provides oversight to assigned medical monitors /li liPresents results to Safety Monitoring Committee and other internal and external meetings /li liMay participate or lead Due Diligence projects in support of CSL’s external innovation efforts /li /ul pDocument Authorship: /p ul liReviews the data generated during the planning and execution of a study to gather a clinical understanding of the safety and efficacy results and the impact of the data on ongoing RD strategies and provides support in defining the development strategy /li li“Lead Author” or “Contributing” Author for key study documents, including but not limited to: the TPP, PSD, CDP, Study Concept Scenarios, Study Outlines, the Investigator Brochure (IB), Clinical Study Protocols (CSP), Master Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Safety Review Committee (SRC)/Independent Data Monitoring Committee (IDMC) Charters, and Clinical Study Reports (CSR) /li liLeads preparations of clinical sections of relevant regulatory interaction packages including but not limited to briefing books, INDs, NDAs. BLAs, ODDs, RFIs, and routine reporting /li liContributing author the publication strategy. Author or contributing author for abstracts, presentations, and manuscripts as appropriate /li /ul h3Minimum Qualifications: /h3 ul liMD, PhD or PharmD in life science/healthcare discipline expected. MD - Board Certified (or non-USA equivalent) in relevant field is preferred. /li li5+ years of relevant clinical development experience in the pharmaceutical industry is expected including experience with study data review/evaluation /li liClinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential Demonstrated program leadership capabilities in a matrixed environment /li liDemonstrated stakeholder management skills including risk mitigation /li liProficient in project management terminology and processes to drive clinical development program risk mitigation strategies /li liExcellent analytical thinking and scientific/medical writing skills /li liProficient in clinical data analysis and interpretation /li liProven effective problem-solving skills and the ability to think critically and make informed decisions /li liDemonstrated effective communication and presentation skills /li liProven ablility to build bridges and proactively improve cross-functional collaboration /li /ul pThe minimum and maximum base salary range that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting is $317,000 - $409,000/yr. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. /p p#LI-HYBRID /p #J-18808-Ljbffr