The Opportunity:Calico's commitment to discovery science led us to Vanishing White Matter (VWM), a rare disease leukodystrophy where chronic dysregulation of the Integrated Stress Response drives disease pathology. Driven by rigorous research, we are dedicated to advancing potential therapies and preparing for the anticipated global launch of Calico's first commercial therapy. To achieve this, we are looking for passionate, driven individuals to build a dedicated team focused on delivering meaningful treatment options to VWM patients and families facing severe unmet medical needs.
Position Description:Calico is seeking a highly strategic Head of Medical Affairs to establish and lead our medical affairs function, translating clinical science into a differentiated, evidence-based narrative for global markets, with an initial emphasis on VWM therapy in US markets. This role reports to the Head of Clinical Development and will be responsible for shaping medical affairs strategy, building infrastructure, hiring and leading our field medical and medical information teams, and accelerating disease-state awareness. Closely collaborating with molecule teams in R&D, they will be serving as a key leader on launch teams as molecules approach approval and a key voice of medicine across the organization.
Key Responsibilities:Strategy & Leadership
- Lead, develop and execute the global medical affairs strategy in alignment with Clinical, Regulatory, and Commercial priorities
- Serve as the Medical Affairs lead on the cross-functional launch team
- Build out core Medical Affairs capabilities to support the launch, including medical communications, field medical team, and post-marketing support functions as needed
- Establish and oversee the external Medical Communications and Medical Information functions, including leading publication planning and execution, developing standard response letters, building global FAQs, and building the infrastructure to efficiently handle unsolicited medical inquiries post-launch
Scientific Engagement
- Cultivate and maintain trusted relationships with global leading Key Opinion Leaders (KOLs), clinical investigators, and expert centers in the rare disease space
- Understand areas of scientific interests and gaps - Design and execute medical education initiatives, advisory boards, and scientific exchange programs
- Lead the development of scientific messaging platform, publication strategy and scientific communication plans
- Develop and implement, in partnership with Commercial colleagues, initiatives aimed at reducing the diagnostic journey, including physician education, screening initiatives, genetic testing efforts, and partnerships with diagnostic specialists and labs
- Partner closely with rare disease patient advocacy organizations to ensure the patient voice is deeply embedded in our medical strategy
Evidence Generation and Compliance
- Oversee early access programs, investigator-sponsored research, and real-world evidence initiatives to support the full product lifecycle
- Design and execute post-marketing requirements and commitments while establishing medical information capabilities and standard response documents
- Collaborate cross-functionally on data interpretation and label optimization
- Ensure all Medical Affairs activities comply with applicable regulations, industry codes, and internal policies
Position Requirements:- Advanced degree required: MD or MD/PhD, PharmD, or PhD in a relevant scientific or clinical discipline
- 10+ years of pharmaceutical/biotech industry experience, with 5+ years leadership in medical affairs; prior experience in clinical practice preferred
- Demonstrated experience leading or building medical affairs functions in a launch setting, including overseeing medical communications
- Deep expertise launching first-in-disease therapies for rare genetic diseases, including orphan drug dynamics, small addressable markets, patient finding, and advocacy engagement
- A commitment to designing strategies around the patient journey and experience
- The capability to comprehend complex clinical data, mechanism of action (MoA), and endpoints, and translate them into clear, compelling, compliant medical affairs strategy
- Experience operating in US health care system, with knowledge of global/international markets also preferred
- Strong understanding of healthcare systems (especially US), compliance guidelines, and the distinct diagnostic and regulatory unique to rare diseases
- Exceptional communication and cross-functional leadership skills with the ability to influence without authority
- Strong ability to work seamlessly across multiple disciplinary experts to achieve shared launch milestones
- Comfort with ambiguity and a hands-on willingness to build a team, create processes, and engage within a larger organization with experienced senior leadership and backing
- Must be willing to work onsite at least 4 days a week
- Ability to travel domestically and internationally (up to ~25%)
The estimated base salary range for this role is $310,000 - $420,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.
