Senior Medical Director, Medical Affairs

Beeline Medicines • Boston, MA

2d • $293,000 - $345,000 • Hybrid

About The Position

The Senior Medical Director, Medical Affairs is a senior therapeutic and disease area expert who serves as the organization's primary external medical and scientific resource for healthcare providers (HCPs), key medical experts (KMEs), clinical investigators, healthcare plans, hospital formulary decision-makers, and patient advocacy organizations. This role operates at the intersection of scientific leadership and external engagement — building and sustaining trusted peer-level relationships within the I&I community while driving the development and execution of the organization's medical affairs strategy most notably for the Beeline Medicines lead program; an investigational selective, oral, once-daily TLR7/8 inhibitor advancing into pivotal development for systemic and cutaneous lupus erythematosus — and for the broader I&I portfolio. The Senior Medical Director leads scientific exchange, supports evidence generation, shapes medical education and KME engagement programs, and serves as a senior internal scientific authority — providing medical input to clinical development, commercial readiness, market access, and regulatory strategy. The Senior Medical Director also serves as a medical reviewer and signatory on the promotional and medical review (MLR) committee for all externally facing company materials for health care professionals, advocacy groups and allied health care functions globally, ensuring factual accuracy and compliance with industry codes of conduct and regulations Reporting to the SVP of Clinical Development and Medical Affairs, this individual brings deep scientific expertise in autoimmune disease, demonstrated KME relationship management, and the strategic leadership presence required to drive the medical affairs function forward in a clinical-stage, resource-efficient biotech environment.

Requirements

• Advanced clinical degree (MD or DO) required.
• Board certification or clinical training in rheumatology, dermatology, nephrology, immunology, or a related specialty strongly preferred.
• Minimum of 5 years clinical and 5 years pharmaceutical/biotech industry experience in medical affairs inclusive of supporting product launches preferred
• Direct experience managing or advising lupus clinical programs strongly preferred.
• Deep scientific expertise in autoimmune disease — specifically lupus (SLE and/or CLE), rheumatology, and/or nephrology — required.
• Established KME network within the lupus, rheumatology, and dermatology communities strongly preferred.
• Experience supporting a registrational or pivotal program through pre-launch medical affairs readiness — including major congress data disclosure, field medical build-out, and compliant pre-approval payer engagement — strongly preferred.
• Deep clinical and scientific expertise in immunology and inflammation — with primary depth in lupus nephritis, SLE, and/or CLE — including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches.
• Demonstrated ability to critically evaluate, synthesize, and communicate complex clinical and scientific literature — including clinical trial data, real-world evidence, and regulatory data packages — to diverse internal and external audiences.
• Experience supporting regulatory submissions, label negotiations, or advisory committee preparations from a medical affairs perspective; familiarity with promotional review processes and compliance frameworks governing medical communications.
• Working command of the compliance framework governing pre-approval scientific exchange — medical–commercial separation, non-promotional communication standards, reactive-only handling of unapproved-use inquiries, the PhRMA Code, FDA OPDP guidance, and applicable EFPIA/ABPI codes — together with transparency obligations including Open Payments reporting of transfers of value.
• Prior experience with advisory board design, scientific meeting planning, ISR program oversight, HEOR strategy, and external expert relationship management in a pharmaceutical or biotech medical affairs context.
• Senior medical affairs leader with demonstrated ability to define and execute medical strategy, lead cross-functional medical initiatives, and operate with significant independence in a lean, clinical-stage biotech environment.
• Proven external relationship leader — builds and sustains trusted, long-term relationships with national and regional KMEs, clinical investigators, and patient advocacy organizations through scientific credibility, consistent follow-through, and genuine commitment to advancing medical knowledge.
• Influential cross-functional partner — drives alignment across Medical Affairs, Clinical Development, Regulatory, Commercial, and Market Access through strong scientific authority and the ability to translate medical insights into organizational action via clear, prioritized medical actions and strategic recommendations.
• Exceptional scientific and medical communicator — engages KMEs, investigators, HCPs, payers, and patient advocacy leaders in substantive, peer-level scientific dialogue with depth, balance, and clarity appropriate to each audience.
• Skilled presenter and medical content developer — prepares and delivers compelling presentations, advisory board materials, and scientific updates to external experts, cross-functional leadership, and executive audiences with precision and strategic framing.
• Strong active listener and external insights integrator — synthesizes KME perspectives, clinical practice trends, and competitive intelligence into actionable medical strategy recommendations that inform organizational decision-making.

Nice To Haves

• Additional advanced degree (PhD, MPH, or MBA) is a plus.
• Position may require ability to travel 30%+ as needed of time or more including occasional overnight stay driven by business need

Responsibilities

• Serve as the primary medical and scientific point of contact for KMEs, clinical investigators, HCPs, healthcare plan decision-makers, and patient advocacy groups within the I&I therapeutic area — with a primary focus on lupus (SLE and CLE) across rheumatology, dermatology, and nephrology — building and sustaining trusted, peer-level relationships that advance the organization's scientific and medical objectives. The Senior Medical Director may also support other therapeutic areas as required.
• Define and lead the execution of the medical affairs strategy for the I&I pipeline, including lupus indications — encompassing KME engagement, evidence generation, medical education, advisory board programming, and publication strategy — in alignment with clinical development milestones and corporate goals.
• Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform medical strategy, pipeline positioning, and commercial readiness.
• Monitor and critically assess competitive clinical data and emerging mechanisms to inform differentiation and scientific positioning.
• Partner with Scientific Communications to develop and maintain the core scientific narrative, medical communications platform, and scientific lexicon; including unbranded disease-state and mechanism-of-action education to build external scientific understanding of a novel target ahead of pivotal readouts.
• Lead the design and execution of medical advisory board meetings — identifying and engaging the right scientific experts, developing scientifically rigorous agendas, and ensuring that advisory board insights translate into actionable medical and strategic recommendations.
• Oversee the development and review of medical content — including medical education materials, scientific slide decks, congress abstracts, posters, and manuscripts — ensuring scientific accuracy, regulatory compliance, and strategic alignment across all external communications.
• Partner with Scientific Communications to develop and execute data disclosure and publication plans as executed in accordance with GPP 2022 and ICMJE authorship criteria.
• Lead scientific engagement strategy for major rheumatology congresses, including KME interactions, data communication planning, and insight capture.
• Provide Medical Affairs support for clinical programs, including investigator and site identification, feasibility input, engagement of steering committee members and national coordinating investigators, scientific input to protocol design, and site-facing scientific training in partnership with Clinical Development and Clinical Operations.
• Partner with Field Medical Affairs and MSL teams to ensure accurate, balanced, and up-to-date scientific tools and resources are available and consistently applied in field engagements — participating directly in key field interactions when the scientific complexity or stakeholder importance warrants senior medical presence.
• Provide strategic medical input into data generation initiatives including interventional (phase 3b, 4) and non-interventional trial design (real world evidence approaches, registry studies) to support market authorization of the asset and life cycle management.
• Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, and other departments on the medical interpretation of clinical data, regulatory submissions, payer engagement strategies, and commercial launch planning — serving as a medical affairs voice across all key cross-functional initiatives.
• Perform other duties and responsibilities as assigned

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Senior