Clinical Franchise Leader

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Senior Director, Clinical Franchise Leader, Bacterial Vaccines (m/f/x, 100%)Location: Leiden, Netherlands; Beerse, Belgium; or United States sites. Other locations may be considered.Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.Janssen Vaccines is dedicated to advancing human health by developing potentially transformational vaccines to prevent and intercept life-threatening infectious diseases. We are primarily focused on research and development, with core expertise in vaccine discovery, development and manufacturing. We have developed a robust pipeline with assets from pre-clinical to phase IV to address high unmet public health needs, including major pathogens such as Respiratory Syncytial Virus (RSV), Extra-intestinal Pathogenic E. coli (ExPEC) and Methicillin-Resistant S. Aureus (MRSA), SARS-CoV-2, Human Immunodeficiency Virus (HIV), and Ebola. A world-class team, cutting-edge technologies and strategic collaborations with world leading experts, policy makers, academic and clinical institutions and other pharmaceutical companies are the driving force behind our efforts.Job responsibilitiesThe position of Clinical Franchise Leader (CFL) acts as the Lead Physician for the group of candidate vaccines within the franchise in Clinical Development, Vaccines. In this role the CFL will provide strategic clinical and scientific oversight in support of vaccine development with particular attention to clinical development. Overseeing the development of the overall clinical project strategies, the CFL will be responsible for the coordination and line management of the Medical Leaders (ML) and Study Responsible Physicians (SRPs) and Scientists (SRSs) assigned to the clinical projects.Furthermore, the CFL is responsible for ensuring a timely and consistent approach to the development of candidate vaccines within his / her Franchise by ensuring a comprehensive strategy across all clinical trials within the appropriate Clinical Development Plans within and, as necessary, across Franchises. Additionally, the CFL will be called upon to provide clinical input on matters regarding pre-clinical development of new vaccines. Finally, in their role as CFL plays an important ambassadorial role and would be expected to develop networks and key working relationships internally within Janssen and with external collaborations.Essential FunctionsStrategic Thinking

• Provides strategic direction and leadership for the Clinical Development Programs for all vaccines in development within the Franchise
• Together with individual Compound Development Teams (CDTs) and Head of Regulatory Affairs, provides input into regulatory strategy. On behalf of management and along with, Clinical Development and Medical Affairs Head and Head of Regulatory Affairs, attends all major regulatory authority interactions
• Together with individual CDTs, Strategic Marketing, and regional and global Medical Affairs, provides input into the commercial strategy for development projects. Provides input to CDTs on overall development strategy (with focus on clinical development) either directly or through the Medical Leader (ML) for the project

People Management

• Provides line management for:
• Medical Leaders and Study responsible physicians and scientists in the clinical franchise
• Supporting our Global Medical Leaders by providing guidance on overall clinical development plan, specific issues/obstacles that arise and by coaching and attention to professional development
• Supports ML through preparation and attendance at First in Human (FIH) committee
• Provides guidance/assistance to ML in cases of the possibility of escalation of issues with other functional leaders

Management Committees

• Actively participates in Clinical Development Committee (CDC), Chair or actively participates in Protocol Review Committee (PRC)
• Functions as a back-up to Head of Clinical Development and Medical Affairs for Clinical topics in other management committees.
• Member of the Sponsor (Executive) Committee for all IDMC (DSMB) for full development programs in the Franchise

Reviews/Approvals

• Reviews all initial TPPs or substantive changes
• Reviews all product labels for vaccines in the Franchise prior to submission to regulatory authorities
• Reviews and provides input into key regulatory submission documents for vaccines in the Franchise

Other

• Keeps Head of Clinical Development and Medical Affairs updated on all relevant aspects of development activities in the franchise in a timely manner
• Provides input for new business opportunities based on clinical and development expertise
• Participates on ad hoc committees/working groups at the request of Clinical Development and Medical Affairs Head
• Assists Head of Clinical Development and Medical Affairs in identifying gaps/inconsistencies in policies/procedures of vaccine medical department helps drive solutions
• Participates in key regulatory interactions (Type C, EOP2, Sci, Adv EMA/PDCO)

Required Certifications

• CH-GCP
• Company SOP/WI relevant to the job

QualificationsEducationMedical Degree requiredExperience

• Minimum 5-10 years industry experience in vaccine development including extensive experience devising Clinical Development Plans, clinical trial protocol development, conduct, data analysis, regulatory submissions and regulatory authority interactions. Vaccine experience is essential; experience with bacterial vaccines preferred
• 2-5 years of experience in people management including direct reports preferred
• Extensive experience working in multifunctional teams
• Clinical practice and/or industry experience in the areas of infectious diseases strongly preferred

Approximately 20-25% travel required (domestic and international).What’s in it for you…?“Caring for the world, one person at a time…”As an employee we consider you as our most valuable asset. We take your career seriously!As part of a global team in an innovative environment your development is key and our day-to-day responsibility.Through e-university, on the job training, various projects and programs, we ensure your personal growth.Our benefits make sure we care for you and your family now and in the future! Primary LocationNetherlands-South Holland-Leiden-Other LocationsUnited States-New Jersey-Titusville, United States-New Jersey-New Brunswick, Belgium-Antwerp-BeerseOrganizationJanssen Vaccines & Prevention BV (8852)Job FunctionR&DRequisition ID2206073605W