About the Role
The Regional Medical Affairs Manager will be 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.
Key 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.
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), and 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 the timely dissemination of clinical data.
Align with Global Medical Affairs on numerous topics (e.g., publication communications).
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.
Preferred Skills
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.
Education and Experience
Advanced degree (MD, DO, PharmD, PhD) in life sciences or related field.
5+ years of experience in medical affairs or clinical development.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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