Senior Medical Director, Bladder/RCC

Job Description

The Senior Medical Director will be responsible for leading several US Medical Affairs activities in support of Bladder Cancer, including but not limited to:

• Provide deep expertise in bladder cancer disease state and treatment, with a focus on the evolving landscape in muscle-invasive bladder cancer.
• Provide strategic medical input for enfortumab vedotin in collaboration with Alliance partners, extended medical team, and cross functional colleagues to support aligned objectives
• Ensure US launch readiness for new assets/indications. Develop and execute short and long-term US Medical plans, aligned with overall business goals.
• Work closely with Global Medical Affairs and other cross-functional colleagues, as appropriate, ensuring that the US Medical Affairs plan is aligned with brand strategies to support successful pre-launch, launch & post-launch medical initiatives.
• Understand and integrate the needs/perspectives of patients and HCPs into Medical plans & tactics.
• Responsible to lead strategic medical partnerships with key external organizations from a bladder cancer portfolio perspective
• Strategic Medical leadership in ongoing sponsored study clinical research.
• Responsible to oversee strategic fit and operational excellence of US ISRs from a bladder cancer portfolio perspective.

ROLE RESPONSIBILITIES

Brand Plan Development

• Oversee and coordinate medical input into brand strategies and tactics, aligning on US regional medical needs.
• Lead the development and timely execution of medical strategies and tactics.

Medical Sub-Team

• Participate, as needed, on Medical sub-team meetings and activities.
• Partnership with Global Medical Affairs to assure US is represented in Global Medical decisions and ensuring GLocal coordination in all activities.

Promotional Materials Review

• Provide clear medical input on promotional and sales training materials, in partnership with Legal, Regulatory and Marketing colleagues, to ensure compliant, accurate, fair-balanced and high-quality content of all commercial materials.

Customer Insight Planning 

• Provide leadership for the development and implementation of customer insight planning (including Advisory Boards) to gather expert guidance to advise medical planning.  

Research

• Develop strategies and manage Investigator-Initiated Research program, Clinical Research Collaborations and analyses of Real World Data.
• Develop and advocate for Phase IV lifecycle clinical trial strategies and concepts to support regional medical business needs

Publication Subcommittee (PSC) Membership

• Collaborate with Global Scientific Communications and Clinical Development on key governance committee to support development of strategic global and regional publication plans.
• Participate in data analysis efforts, and lead or participate in manuscript, abstract, and poster development.

Safety Support

• Represent regional medical on internal safety committees, safety analysis and interpretation of clinical and RWD, guidance for safety updates, issues pertaining to regional business.
• Regulatory Support:  Provide regional medical leadership, support and guidance for new labels, label updates and responses to regulatory requests.

Customer Facing Partnerships

• Partner with expert thought leaders and societies to support regional Medical business goals, including manuscript generation, research partnerships, fellowships, expert guidance, and competitive insight. 
• Provide primary medical leadership & support for regional medical congresses.

Leadership & Mentorship

• Effective leadership within team matrix, excellent interpersonal skills.
• Responsible for developing and coaching other team members as requested.
• Support a high-functioning and performance culture for team

Subject Matter Expertise

• Serve as a medical/clinical expert in the diagnosis and treatment of patients with bladder cancer to bring the voice of patients & physicians to efforts and initiatives

QUALIFICATIONS

• PhD, PharmD, DVM professional degree
• 8 or more years experience in either pharmaceutical industry, academic centers, clinical practice, or a combination of these.
• Experienced in the diagno