photocure
Regional Medical Affairs Manager
Chicago, Illinois, United States
Sponsorship not specifiedDetected 20 days ago
GCPStatisticsClinical TrialsFDA RegulatoryMedical DevicesResearchLeadershipCommunicationProblem SolvingPublic SpeakingBiostatisticsRegulatory Affairs
About the role
- 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.
- This position reports to the VP North America Head of Medical & Clinical Affairs.
Responsibilities
- Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs)
- Leads or supports the design, planning, and execution of clinical projects, which may include interventional, observational, or post-marketing (e.g. Phase 4) studies
- 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
- Help manage vendor performance, timelines, and deliverables
- Support ongoing registry programs with a focus on data quality and site performance
- Collaborate with investigators to produce and support manuscripts
Requirements
- Ability to work cross-functionally in a fast-paced, evolving environment
- Ability to work independently and execute tasks within deadlines
- Ability to travel ~ 50% of time, or as needed, in US, Canada or Europe for KOL visits, SIVs, conferences, etc.
- 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.
Skills
- An understanding of both Medical Affairs and Clinical Development
- Provide clinical input into product development, labeling, and lifecycle management
- Demonstrated experience managing CROs and multi-center clinical studies
- Deep understanding of GCP, regulatory requirements, and clinical data quality standards
- 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
Benefits
- Develop and participate in medical communication, education and training for KOLs
- Assist in the development, implementation, and delivery of Medical Advisory Boards
- Contribute to medical communication and data dissemination
- Align with Photocure Global Medical Affairs on numerous topics (e.g. publication communications)
Visa & Work Authorization
- Act as primary sponsor representative for CROs and vendors
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