Director, Medical Affairs

Position Summary:

• This role will provide management of project related activities for Medical Affairs. They will report directly to the head of Medical Affairs. This individual must be exceptionally organized, diligent, detail-oriented, flexible, team oriented, dynamic and adaptable to a fast-paced start-up environment and have experience in supporting multiple individuals. Duties and Responsibilities:
• Establish collaborative relationships with academic and industry Key Opinion Leaders (KOLs), advocacy groups, and other external stakeholders
• Create and execute KOL development plans, including organization of advisory board meetings, collaboration on publications and educational initiatives. Communicate and coordinate directly with KOLs as needed to support broader organizational needs, e.g. clinical development consultations, investor relations activities, etc
• Provide lead liaison role with Medical Communications vendor in support of publication related activities and all related logistics for abstract submission, poster development and delivery, generation of manuscripts from initiation to final author approval, other med comm related activities, e.g. development of slide resources, scientific lexicon/scientific narrative
• Serve as the medical affairs representative to the Medical, Legal, Regulatory (MLR) review team to ensure materials support brand and company objectives aligned with compliance regulations for the pharmaceutical industry
• Manage all aspects of requesting and tracking nondisclosure/confidentiality agreements, contract agreements, purchase orders, invoicing and budget management support for Medical Affairs.
• Assist with managing the Medical Affairs budget and quarterly reconciliations
• Manage intake and processing of Medical Education Grant and Sponsorship funding requests
• Management of conference calendar and coordinating onsite meetings
• Meeting management - coordinates preparations for advisory board meetings, including ensuring invitations, confidentiality agreements, schedules, meeting logistics, and honorarium payments are appropriately managed
• Provide specific project related work for Clin Ops and work cross-functionally with other functions throughout the organization
• Work closely with clinical trial teams to support clinical trial site recruitment and patient enrollment as needed
• Additional duties as assigned

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

• Advanced degree in a healthcare field (e.g. MD, PharmD, PhD, RN)
• Minimum of 5+ years of content development/ content strategy in the pharmaceutical industry required
• Respiratory experience is preferred
• Pre-launch experience is a plus
• Experience working in biotech or pharmaceutical company
• Clear understanding of compliance regulations governing the pharmaceutical industry
• Understanding of the commercial driver of product marketing success and ability to partner in a compliant way with the commercial organization
• Has some relevant experience in a medical affairs capacity, or similar function
• Broad understanding of the role medical affairs plays

Competencies:

• Able to read, comprehend, write, and speak English fluently
• Excellent written and verbal communication and interpersonal skills. Able to communicate complex information clearly and succinctly, both in writing and orally
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries
• Able to understand scientific concepts and data and translate them into written and oral communication
• Proficient proofreading and editing skills
• Ability to collaborate effectively with the cross-functional teams and external partners
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), SharePoint, Adobe, Zoom
• Strong business acumen
• Must be analytical, highly detail-oriented and have strong organizational and time management skills
• Proactive thinker who is proficient at problem solving under pressure, is resourceful and compelled to action
• Demonstrated project management experience with the ability to multi-task, manage and prioritize various and differing projects, as well as work effectively with a strong sense of urgency toward numerous deadlines
• Flexible, positive and adaptive attitude and to provide hands-on support to the team when necessary to meet tight timelines
• Must be self-motivated and able to work independently with minimal supervision

Posted On: Monday, April 14, 2025