Vice President Remote Project Manager Jobs in Edison, NJ

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 Legend's 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 programming.   In 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+ MSL's 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 team's 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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