Regional Medical Affairs Manager

Key Responsibilities And Activities

• 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
• Aid in the development, implementation, and delivery of Medical Advisory Boards
• 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