Regional Medical Affairs Manager

The Regional Medical Affairs Manager (RMAM) is a cross functional role responsible for the strategic planning, execution, and delivery of bladder cancer studies and other medical affairs activities. The role interacts with HCPs and key opinion leaders to lead clinical studies and medical affairs activities to generate high-quality clinical and real-world evidence to support medical communication, regulatory submissions, scientific publications, guidelines and product adoption. This position reports to the VP North America Head of Medical & Clinical Affairs.

Key Responsibilities and Activities:

External Expert Engagement:

• Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs)
• Develop and participate in medical communication, education and training for KOLs
• Identify data gaps related to disease area or products based on clinical insights
• Participate in local and national congresses
• Assist in the development, implementation, and delivery of Medical Advisory Boards

Clinical Study Leadership & Execution:

• Leads or supports the design, planning, and execution of clinical projects, which may include interventional, observational, or post-marketing (e.g. Phase 4) studies
• Provide input into study protocols, investigator brochures, statistical analysis plans, and clinical study reports
• Drive study timelines, budgets, and milestones to ensure successful delivery
• Lead site identification, feasibility assessments, and Site Initiation Visits (SIVs)
• Support onboarding and training of investigators and study staff
• Act as primary sponsor representative for CROs and vendors
• Help manage vendor performance, timelines, and deliverables
• Contribute to the management of sponsor studies, investigator-initiated studies (IIS/IITs), research collaborations from a scientific and operational perspective
• Support ongoing registry programs with a focus on data quality and site performance

Publications & Evidence Dissemination:

• Contribute to medical communication and data dissemination
• Contribute to publication strategy, including abstracts, manuscripts, and presentations at scientific congresses (e.g., AUA, EAU)
• Collaborate with investigators to produce and support manuscripts
• Keep internal stakeholders informed to ensure timely dissemination of clinical data
• Align with Photocure Global Medical Affairs on numerous topics (e.g. publication communications)

Core Competencies / Knowledge & Skills:

• Ability to Partner with Regulatory, Market Access, and Commercial teams to align clinical evidence needs
• An understanding of both Medical Affairs and Clinical Development
• Provide clinical input into product development, labeling, and lifecycle management
• Support internal training with clinical data and study insights as needed
• Strong expertise in clinical trial design, execution, and operations
• Demonstrated experience managing CROs and multi-center clinical studies
• Deep understanding of GCP, regulatory requirements, and clinical data quality standards
• Ability to lead complex projects and manage multiple stakeholders
• Strong analytical, problem-solving, and communication skills

Education, Experience & Training:

• Advanced degree (MD, DO, PharmD, PhD) in life sciences or related field
• 5+ years of experience in medical affairs or clinical development
• Experience in urology, oncology, or medical device/diagnostics strongly preferred
• Experience with bladder cancer or cystoscopy technologies is desirable
• Experience supporting regulatory submissions and publications a bonus

Additional Requirements:

• Ability to work cross-functionally in a fast-paced, evolving environment
• Ability to work independently and execute tasks within deadlines
• Knowledge of PhRMA, OIG and other guidelines relating to compliant medical communications
• Demonstrated expertise in ability to synthesize and communicate medical information clearly.
• Excellent oral and written communication skills
• Ability to travel ~ 50% of time, or as needed, in US, Canada or Europe for KOL visits, SIVs, conferences, etc.

Significant Contacts:

• Internal: Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Medical Affairs, Market Access, Commercial, Legal
• External: Investigators, clinical trial sites, CROs, CRAs, vendors, regulatory authorities