VP of Medical Affairs

Role Overview

The VP of Medical Affairs is an essential role in the company with significant impact on the development and life cycle of drug development projects. The VP of Medical Affairs will provide strategic leadership as directed by the Chief Medical Officer to develop integrated Medical Affairs Strategy, working closely with co-development partners, such as JnJ, as well as partners within the company such as the Commercial organization, 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 and executing on existing and new product development and launches, leading ad-boards, scientific meetings, symposia, and other continuing medical education activities as well as be instrumental in KoL engagements.

Key Responsibilities  

• Oversee a team of 12+ MSL’s plus one MSL Head, as well as other medical affairs members including Scientific Communications, Medical Information etc.
• Oversee all medical functions including Medical Strategy, Thought Leader Engagement, Publications and Data Generation, Medical Information.
• Work closely with co-development partners such as JnJ ensuring that Legend strategy is represented and alignment is achieved on critical matters.
• Responsible for helping clinical community understand the role of CAR-T as a new SOC in earlier lines of treatment (including 2nd line per label and also front-line per studies currently enrolling).
• This position sets the strategic direction and oversees the tactical implementation of the field-based medical team.
• Lead & create the U.S and global Medical Affairs Strategy for all marketed or new indications, working closely with stakeholders, cross functional teams and with collaboration partners.
• Lead and oversee the execution of the following U.S. and Global strategic plans for medical affairs:
  • Strategic and Tactical Plan
  • Launch plans for new products or new indication launches
  • Publication team and plans
  • KOL management plan
  • Sponsorship and CME planning oversight
  • Departmental budget oversight
• Drive major international Congress Planning, strategically targeting relevant meetings and assuring data for development programs meets strategic objectives. Attend medical scientific meetings and congresses to represent the company
• Oversee and endorse publication strategy and timelines proposals by publication team. Provide review and approval for publications as the medical lead.
• Oversee ongoing disease and product training activities (including launch training to MSLs, speaker bureau, & commercial in collaboration with other stake holders).
• Contribute medical affairs strategy and deliverables to the global development plan for each molecule 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.
• Assure that functional deliverables are completed on time, within budget and according to the highest quality, ethical and professional standards.
• 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.
• Assist in the initiation, oversight and follow up of medical projects such as: post market clinical activities (Phase IV); registry projects; and epidemiological surveys. Ensure, all such activities comply with applicable local regulations.
• Oversee and manage 17-20+ medical affairs team members. Will have 2-6 direct reports and work closely with other company partners that Legend collaborates closely with creating a partnership.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork.
• Ensures 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 develop and execute integrated evidence generation plan and build best-in-class medical capabilities.
• Demonstrated ability to shape treatment landscapes through compelling medical strategies and plans.
• Deep relationship with the multiple myeloma KOL community is strongly preferred.
• 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.
• Prior oncology or malignant hematology experience, particularly in multiple myeloma. Prior cellular therapy experience is a plus. Prior myeloma experience is a plus.
• 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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