Medical Affairs Specialist

Role Objectives:

The Ideal Candidate:

• Analytical
• Adaptable
• Detail Oriented
• Problem Solver

What You'll Do:

• Act as the primary medical contact for investigators, regulatory bodies, and internal/external stakeholders, ensuring consistent interpretation and clarification of study protocols.
• Oversee clinical trials and/or Expanded Access Programs (EAP) to ensure participant safety, data accuracy, and adherence to protocols, addressing medical issues as they arise.
• Support investigator site selection by evaluating qualifications, experience, and suitability during feasibility discussions and selection processes.
• Lead and participate in investigator calls to discuss inclusion/exclusion criteria and provide tailored support to optimize site engagement and patient recruitment.
• Serve as the lead medical expert on study protocols, ensuring full comprehension and adherence across all involved parties.
• Conduct and contribute to investigator meetings, site initiation visits, and study-related training sessions to explain protocol requirements and resolve medical concerns.
• Provide continuous medical training and support to investigators, site personnel, and internal teams, ensuring alignment with study objectives and therapeutic area knowledge.
• Review adverse events (AEs) and serious adverse events (SAEs), perform causality assessments, and ensure accurate, timely safety reporting.
• Collaborate with Data Safety Monitoring Boards (DSMBs) and other safety committees to monitor ongoing trial safety and provide medical oversight.
• Contribute medical expertise to the development of study documents, including protocols, treatment guidelines, and methodology, ensuring scientific rigor and ethical compliance.
• Ensure study conduct aligns with protocol and regulatory requirements by identifying, classifying, and resolving deviations in collaboration with cross-functional teams.
• Represent Medical Affairs in external engagements such as bid proposals, defense meetings, and client presentations, while supporting internal teams with protocol-related guidance.

What You'll Need:

• Minimum bachelor’s degree in health-related science and/or healthcare credentials (RN, PharmD, MD); advanced degree preferred
• At least 5+ years of relevant clinical research experience, preferably in medical monitoring or equivalent combination of education and experience
• Willingness and ability to travel domestically and internationally as needed for business meetings, bid defenses, trainings and/or industry events
• Experience in EAP / CUP / NPP is preferred
• Proven experience in protocol development, implementation, and interpretation
• Experience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trials
• In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes
• Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint
• Strong leadership, communication, and collaboration skills across diverse teams and stakeholders
• Proven analytical, problem-solving, and decision-making abilities in complex healthcare settings
• Highly organized, with the ability to work independently and as part of a team

What We Offer:

What Sets Us Apart:

We're Committed to Our Team:

We're Committed to DEI:

Our services include: