VP, Medical Affairs

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Bridgewater New Jersey we are advancing the next generation of cell therapy through a portfolio of innovative technologies including autologous allogeneic and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T) T-cell receptor (TCR-T) natural killer (NK) cell-based therapies and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites we are committed to discovering and developing safe effective and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a VP of Medical Affairs as part of the Medical Affairs team based in Bridgewater NJ.

Role Overview

The VP of Medical Affairs is an essential role in the company with significant impact on the clinical understanding of Legends approved BCMA CAR-T for multiple myeloma as well the development of pipeline programs. The VP of Medical Affairs will provide strategic leadership to develop and execute an integrated Medical Affairs Strategy working closely with collaboration partners such as Johnson & Johnson as well as partners within the company such as Commercial Clinical Development Translational Development Safety Regulatory Healthcare Compliance and Legal. Core responsibilities will encompass developing & executing medical affairs strategy and providing leadership and direction to the medical affairs team (home office and field-based) and executing on significant initiatives including scientific communications publications lifecycle planning data generation KOL engagement and educational addition this leader will help build Medical Affairs capabilities to support our emerging pipeline.

This position reports to the President of the CARVYKTI business unit and is a member of the CARVYKTI leadership team with close collaboration with the President of R&D.

Key Responsibilities

• Positively impact the educational and clinical needs of the multiple myeloma-treating community (and more broadly the hematology community) in understanding the role of BCMA CAR-T in the treatment landscape including its use earlier in the treatment paradigm.
• Oversee a team of 16 MSLs plus MSL management and ensure they have high impact in the activities and programs they conduct.
• Lead and inspire a highperforming Medical Affairs team by cultivating a culture of trust engagement inclusion and continuous development ensuring strong talent retention and succession.
• Oversee all medical functions including Medical Strategy Thought Leader Engagement Publications and Data Generation Medical Information etc.
• Work closely with collaboration partners such as Johnson and Johnson ensuring that Legend strategy is represented and alignment is achieved on critical strategic scientific operational and financial matters.
• Lead and oversee the execution of the following U.S. and Global strategic plans for medical affairs:
  • Strategic and Tactical Plan grounded in clinical and scientific insights
  • Launch plans for new products or new indication launches
  • Publication plans
  • Sponsorship and CME
  • Congress planning data presentation and thought-leader engagement
  • Departmental budget oversight
• Contribute medical affairs strategy and insight to the global clinical development plan for new programs in development if applicable.
• Lead company sponsored non-registration trials lead secondary analyses of primary data (in collaboration with Clinical Development) lead registries or research involving 3rd Party databases.
• Maintain high level timelines and detailed timelines for all medical affairs deliverables. Effective consistent & regular tracking of project timelines to allow full transparency to the senior leadership.
• Demonstrated ability to build effective working relationships influence negotiate and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed.
• Identify project risks with input from the cross functional teams and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership with proactive mindset.
• Assure that the highest quality ethical & professional values are demonstrated in all aspects of the teams work.
• Ensure compliance with corporate policies and procedures as well as all related healthcare laws and regulations.

Requirements

• MD (preferred) PhD PharmD or relevant advanced degree with 10 years of experience in pharma or biotech drug development (preferred) or academia.
• Demonstrated ability to build best-in-class medical capabilities.
• Demonstrated ability to shape treatment landscapes through compelling medical strategies and plans.
• Extensive knowledge of drug development and/or experience in more than one functional area such as clinical med affairs translational development regulatory commercial safety etc. to assure broad understanding of the pharmaceutical development.
• Relationships with the multiple myeloma KOL community is preferred. Prior oncology or malignant hematology experience particularly in multiple myeloma and/or prior cellular therapy experience is preferred.
• Prior NDA or BLA filing/submission & launch experience is a plus.
• Good understanding of GCP and medical affairs compliance and good practices.
• Knowledgeable of competitive products and their application.
• Product lifecycle management experience.
• Superior interpersonal skills & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence.
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.
• Strong track record of delivering results through effective team and peer leadership in matrix.
• Excellent leadership & organizational skills analytical skills presentation skills and strong experience in translating medical/clinical information into medical affairs strategies.

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.