Senior Medical Director, US Immunology Medical Affairs

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provide strategic and scientific leadership in the medical field for immunology products.

• Become an expert in the disease state and product, offering valuable feedback and insights for medical affairs deliverables and cross-functional partners, including the design and execution of Medical Affairs plans.

• Collaborate closely with the medical field team to develop and enhance engagement plans for Key Opinion Leaders (KOLs) and key institutions, positioning Sobi Inc as the preferred scientific partner.

• Assist in planning and executing advisory boards to gather expert opinions.

• Develop a medical education strategy and implement tactics to enhance understanding of the product and disease state (webinars, medical roundtables, symposiums, congress presence, and CME strategy).

• Partner with the field medical team to identify key resource needs and work together on field materials and tactics.

• Collaborate with the team to create a medical training plan and provide educational support to cross-functional partners.

• Formulate a US immunology product evidence generation strategy that meets the needs of stakeholders (HCPs, payers, and patients), collaborating with HEOR and global partners.

• Supervise medical affairs-led research initiatives, including US Phase IV clinical programs, post hoc analyses, and natural history studies, to address US-specific needs.

• Additionally, the Senior Medical Director will play a crucial role in global life cycle management activities, including future indication programs, cytokine testing, Investigator-Initiated Study strategy, and overall contribution to the creation and execution of product evidence generation plans.

• Manage the US product publication strategy and execution while also contributing to the global publication plan and its outputs.

• Collaborate with scientific communications to ensure timely dissemination of key scientific data and its integration into field materials and other educational resources.

• Design and implement a medical advisory plan, gather medical insights, partner with the field team, and share findings internally.

• Analyze insights to make adjustments to strategy and tactics.

• Build and maintain strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales and Marketing, Global product leadership, Global medical affairs, and clinical development, offering strategic medical insights and expertise on products and disease states to meet business objectives.

• Provide medical expertise to support the market access team during discussions and presentations with payers.

• Work closely with global medical and clinical colleagues to ensure that US perspectives and insights are incorporated into global initiatives.

• Engage with Key Opinion Leaders, Regulatory Authorities, Patient advocacy groups, and other external agencies to advance company objectives and improve patient outcomes.

• Lead or support US product medical activities, including the US brand medical team.

⛳️ Requirements

• Advanced degree (e.g., MD, PharmD, or PhD) in life sciences.

• 10+ years of experience in pharmaceutical/biotech medical affairs and/or R&D, including prior roles as a senior medical affairs director.

• Previous experience in rare diseases or immunology is preferred.

• Strong scientific and clinical acumen, along with strategic and analytical abilities, to effectively communicate and present complex scientific concepts.

• Experience in identifying and developing solutions for data gaps, as well as developing, presenting, and publishing clinical data.

• Excellent interdepartmental collaboration skills, with the ability to work effectively with customers and colleagues at all levels in a cross-functional team environment.

• Proven leadership and team-building capabilities, inspiring others by fostering a positive climate.

• Knowledge of US-specific legal, regulatory, and compliance regulations and guidelines.

• A results-driven mindset with a sense of urgency, solution orientation, and innovation.

• A strong enthusiasm and passion for work, along with kindness and empathy.

• A patient-focused approach is essential!

🏝️ Benefits

• Competitive compensation for your efforts.

• Generous time off policy.

• Opportunities to expand your knowledge by attending renowned conferences.

• A strong emphasis on maintaining work/life balance.

• A collaborative and team-oriented work environment.