Senior Medical Director , US Immunology Medical Affairs

About the role

The Senior Medical Director supports the medical business goals and objectives of one to two Immunology products, providing strategic leadership and tactical execution. This position reports to the Vice President of Immunology North American medical affairs.

Responsibilities

• Provide strategic and scientific medical leadership for immunology product(s). Become a disease state and product expert, providing feedback and insights to medical affairs deliverables, and cross-functional partners, including the design and implementation of Medical Affairs plans
• Work closely with the medical field team to develop/enhance KOL and key institution engagement plans and participate in KOL engagement and development, establishing Sobi Inc as a scientific partner of choice. Help plan and execute advisory boards to obtain advice. Create a medical education strategy and drive tactics to increase product and disease state education (webinars, medical roundtables, symposium, congress presence, CME strategy)
• Partner with the field medical team to identify key resource needs and to collaborate on developing field materials and tactics. Additionally, partner with the team to establish a medical training plan and provide training/education to cross-functional partners.
• Develop US immunology product(s) evidence generation strategy to address stakeholder (HCPs, payers, and patients) needs (including product differentiation, health outcomes), collaborating with HEOR and global partners. Oversee any medical affairs-led research initiatives, including US Phase IV clinical programs, post hoc analyses, and natural history studies, to address US needs. Additionally, the Senior Medical Director will be a key contributor to the global life cycle management-led activities, including programs for future indications, cytokine testing, Investigator-Initiated Study strategy, and overall input into the creation and execution of product evidence generation plans
• Oversee the US products publication strategy and execution, as well as contribute to the global publication plan and publications.
• Partner with scientific communications to ensure timely dissemination of key scientific data and its incorporation into field materials and other educational resources.
• Design and implement a medical advisory plan, collate medical insights, partner with the field team, and share them internally. Analyze insights for adjustment to strategy and tactics
• Develop and foster 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, providing strategic medical insight and product/disease-state expertise to meet business objectives.
• Support the market access team as needed with medical expertise and in discussions/presentations to payers
• Collaborate closely with global medical and clinical colleagues, ensuring US perspective and insights are incorporated into global initiatives
• Interact with Key Opinion Leaders, Regulatory Authorities, Patient advocacy groups, and other external agencies in support of our products/ therapeutic areas of interest to advance company objectives to improve patient outcomes
• Lead, or help lead, 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 pharmaceutical/biotech experience in medical affairs and/or R&D, including prior senior medical affairs director experience
• Previous experience in rare disease or immunology, preferred
• Strong Scientific and clinical acumen, as well as strategic and analytical abilities, to effectively communicate and present complicated scientific concepts
• Experience in identifying and developing solutions to data gaps, as well as developing, presenting, and publishing clinical data.
• Excellent interdepartmental partnering ability, including the ability to effectively work with customers and colleagues, and the ability to work effectively in a cross-functional team environment; the ability to work with people at all levels
• Demonstrated leadership and team-building skills; able to inspire others by fostering a positive climate
• Working knowledge of US-specific legal, regulatory, and compliance regulations and guidelines
• Drive for results with urgency, solution-orientation, and innovation
• Enthusiasm and passion for work, kindness, and empathy
• Patient focus a must!

Qualifications

• Advanced degree (e.g., MD, PharmD, or PhD) in life sciences
• 10+ years of pharmaceutical/biotech experience in medical affairs and/or R&D, including prior senior medical affairs director experience
• Previous experience in rare disease or immunology, preferred
• Strong Scientific and clinical acumen, as well as strategic and analytical abilities, to effectively communicate and present complicated scientific concepts
• Experience in identifying and developing solutions to data gaps, as well as developing, presenting, and publishing clinical data.
• Excellent interdepartmental partnering ability, including the ability to effectively work with customers and colleagues, and the ability to work effectively in a cross-functional team environment; the ability to work with people at all levels
• Demonstrated leadership and team-building skills; able to inspire others by fostering a positive climate
• Working knowledge of US-specific legal, regulatory, and compliance regulations and guidelines
• Drive for results with urgency, solution-orientation, and innovation
• Enthusiasm and passion for work, kindness, and empathy
• Patient focus a must!

Skills

• Strategic and scientific medical affairs leadership
• Collaborative and patient-focused approach
• Effective communication and analytical skills
• Knowledge of US-specific legal, regulatory, and compliance regulations

Benefits

• Comprehensive medical, dental, and vision package
• Tuition and wellness reimbursements
• A competitive 401(k) match
• Short-term and long-term bonuses

Pay

Base salary range for this role is $260K – $295K. Each individual offer will be determined based on several factors, including your experience, qualifications, and location.

Schedule

Full-time

Company Description

At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute.