Associate Director, Medical Affairs

Job Summary:

Associate Director, Medical Affairs supports the Medical Affairs team in communicating scientific, clinical, and technical information through strong collaborative relationships with internal and external stakeholders. This position will provide operational and strategic support to execute Medical Affairs goals and objectives. This position will facilitate onboarding and training functions within the Medical Science Liaison team as well as cross functional onboarding of Commercial team members. This position will oversee Medical Affairs functions for creating and submitting pieces through the Medical Review Committee. This position will align with Medical Affairs strategy and provide critical project management support by maintaining records for Independent Medical Education and Grants and Investigator Initiated Study functions.

Essential Functions:

• Assists the Head of Medical Affairs in developing the vision, strategy, direction, operating plans for Medical Affairs programs while ensuring alignment with key stakeholders.
• Ensures development and delivery of medical materials/presentations in alignment with Medical Affairs strategy and takes a lead role in Promotional Advertising Review Committee (PARC) and Medical Review Committee (MRC) submission and review process.
• Leads Medical Affairs project management related to sponsored clinical trials, investigator-initiated studies, external collaborative research.

• Participates in the Investigator Initiated Study process for related projects. Convenes committees and keeps minutes for associated functions.
• Has a solid understanding and adherence to Standard Operating Procedures/Rules/Regulations regarding internal/external UroGen/customer interactions and activities.
• Maintains regular updates and revisions for Standard Operating Procedures and facilitates renewal and submission through DOT Compliance software.
• Manages literature database currently called Article Galaxy with appropriate references pertaining to approved and unapproved products, guidelines, and disease state information.

• Coordinate Speaker Bureau alongside Marketing Team specifically the annual Speaker Program training, update Speaker Program training, logistics, and post Speaker Program evaluation.
• Establishes strong and compliant relationship with Commercial leadership to foster appropriate alignment between Medical Affairs and Commercial teams' strategy and operational execution. Holds training sessions for Commercial team members as needed.
• Assists in the planning and execution of Congress activities.

• Works closely on collaborative projects amongst Medical Affairs and other departments for planning and execution of Medical Affairs activities including conference planning, advisory boards, publication planning, field force training, creation and review of standard response letters, HEOR analysis and review of promotional materials and marketing initiatives.

Requirements:

• Terminal degree (PhD, PharmD, or another doctorate)
  • An equivalent combination of education and applicable job experience may be considered.
• Urologic Oncology and rare disease experience a plus
• Excellent oral and written communication skills, including presentation skills
• Excellent and demonstrated interpersonal skills: ability to understand and respond to multiple external and internal customers' demands, manage and handle conflict constructively
• Demonstrated clinical or scientific technical skills including experience working with clinical trials.
• Be a self-starter, accountable, and have a sense of urgency in delivering results that have impact.
• Work collaboratively with Medical Affairs and cross functional teams.
• Collaborate effectively and demonstrate leadership and teamwork with peers, internal and external stakeholders that inspires alignment and partnership on a shared vision or strategy.
• Ability to travel including periods of up to 60% at which includes overnight travel.