Regional Medical Affairs Manager

Photocure•Chicago, IL

3d•Remote

About The Position

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.

Requirements

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
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
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.

Nice To Haves

Experience with bladder cancer or cystoscopy technologies is desirable
Experience supporting regulatory submissions and publications a bonus

Responsibilities

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
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
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)