Senior Director, Scientific Affairs – Medical Education

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Medical Affairs review process within the Medical, Legal, and Regulatory framework for both promotional and non-promotional materials.

• Manage scientific substantiation requirements, claims matrices, references, annotations, and ensure alignment with approved prescribing information and the scientific platform.

• Create MLR SOPs, establish review timelines, and coordinate reviewer training with Legal, Regulatory, and Compliance teams.

• Identify medical education materials, target audiences, sequencing, and ensure alignment with medical priorities.

• Develop strategies for residency curricula and educational initiatives across key medical specialties.

• Direct independent medical education grant strategies and reviews while ensuring compliance with ACCME standards.

• Ensure consistent scientific positioning throughout the scientific platform and Clinical Council subdomain hubs.

• Act as the primary Medical Affairs liaison with Commercial leadership regarding cytisinicline scientific messaging.

• Forge and implement partnerships with specialty societies, continuing education platforms, EHR integration partners, quit lines, and public health organizations.

• Apply FDA regulations, the PhRMA Code, and pre-approval communication guidelines to medical strategies and materials.

• Report directly to the SVP of Medical Affairs, with a dotted line to the Chief Medical Officer.

• Be prepared to travel up to 25% for conferences, medical education events, company meetings, and other business necessities.

⛳️ Requirements

• An MD, PhD, PharmD, or another advanced scientific or clinical degree relevant to the role.

• Over 10 years of experience in Medical Affairs, medical communications, or medical strategy on the agency side.

• Proven experience as an MLR medical reviewer.

• In-depth understanding of FDA promotional requirements, scientific exchange, the PhRMA Code, and ACCME standards.

• A track record of success in developing medical education strategies and multichannel scientific dissemination initiatives.

• Ability to reconcile commercial priorities with scientific integrity and provide constructive communication regarding boundaries.

• Strong leadership and stakeholder management skills across cross-functional teams.

• Experience in establishing processes and capabilities within an expanding organization.

• Preferred: Experience in supporting the launch of a pharmaceutical product.

• Preferred: Knowledge in substance use disorder, addiction medicine, tobacco treatment, or a related therapeutic field.

• Candidates can be located anywhere within the continental United States.

🏝️ Benefits

• Annual target bonus.

• Equity compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan.

• Employee Stock Purchase Plan.

• Company-paid life insurance.

• Short- and long-term disability coverage.

• Paid time off.

• Paid company holidays.

• Remote work arrangement.