Senior/Executive Director, Global Medical Operations & Patient Advocacy

Reporting to the GVP of Medical Affairs, the Senior Director/Executive Director, Medical Affairs Operations will be responsible for establishing and managing processes and standards for the internal and field based Medical Affairs teams and corresponding projects in alignment with organizational goals and objectives.  This role requires a person who can collaborate cross-functionally to create an industry-leading medical affairs operational framework and who can also work independently in a fast-paced and demanding environment.  This position is responsible for working across Kiniksa’s programs and departments to ensure successful delivery of projects in a timely manner and according to the approved budget.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):

Overarching Objectives

• Shape and implement a global patient advocacy and engagement strategy across Kiniksa’s portfolio that will ensure Kiniksa’s continued support of existing initiatives and prepare us for future product launches.
• Lead efforts that reinforce a patient-focused culture throughout Kiniksa by implementing company-wide patient engagement, educational, and/or volunteer programs as well as oversee all external patient advocacy and engagement efforts.
• Lead Medical Affairs cross-functional scientific congress strategic planning including development/refinement of objectives, materials, and medical information booth.
• Oversee the department of Medical Information to ensure the compliant, scientifically-sound, unbiased provision of medical information, while upholding strong quality & service standards.
• Lead the development of Medical & Patient Engagement reports and/or presentations to highlight key achievements, share insights, and track departmental performance.
• Leverage scientific acumen and excellence expertise, to provide dynamic training support and ensure Medical Affairs team is prepared for scientific exchange with HCPs.
• Spearhead innovative process improvement initiatives to enable successful activities and support information dissemination; keep abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
• Oversee Medical Affairs departmental budget, including quarterly forecasting and planning.
• Manage, train, mentor, and professionally develop Medical Information/Patient Advocacy direct reports.

Medical Operations

• Lead Medical Affairs cross-functional strategic congress planning and Medical Information congress activities; including face to face attendance and provision, plus coordinating activities with commercial colleagues where relevant, to include pre and post con briefings.
• Oversee Medical Information overall strategic and operational plan.
• Provide oversight of the development of medical information resource documents and in the handling of medical information requests/initial intake of spontaneous adverse event and/or product complaints.
• Create a strategy to enhance or create channels for responding to unsolicited requests for medical information or communicating key scientific information about our products.
• Participate in the development of SOPs for activities conducted by Medical Affairs and ensure that all activities are in compliance with ICH and other international regulatory guidelines and follow relevant GCPs and SOPs.
• Oversee process for cross-functional evaluation and management of Managed Access requests.
• Collaborate internally to evaluate external Medical Education opportunities in order to increase scientific understanding.

Patient Advocacy

• Perform an ongoing landscape assessment of rare cardiovascular disease advocacy in the United States and Europe.
• Establish and/or further develop and continuously strengthen advocacy relationships with national and community organizations through compliant and thoughtful engagement and alignment on company priorities.
• Identify, engage, and develop strong partnerships with internal colleagues, across key functions (e.g. Patient Services, Patient Marketing, Corporate Communications, Medical Information) to support a cohesive engagement strategy.
• Determine the appropriate timing and level of patient advocacy and engagement activities with communities aligned with Kiniksa’s clinical development pipeline.
• Communicate key learnings from the patient community to inform cross-functional (ie: medical, clinical, and commercial) team strategies.
• Develop the agenda and manage the conduct of patient advisory boards and patient advocacy meetings/summits.
• Identify opportunities for patients and patient advocates to participate in development of educational materials, review clinical study protocols and other documents and programs (e.g., informed consent, clinical trial recruitment, patient, and product services, etc.)
• Establish best practices for communicating with patients who reach out to Kiniksa proactively via phone, email, etc. in line with medical information processes
• Maintain current working knowledge of industry and healthcare legislation relevant to patient advocacy such as incorporating the patient voice in clinical development and communicate as appropriate to internal and external partners.

Standout Skills for Impact:

• Proven ability to establish and manage strategic partnerships with patient advocacy groups, ensuring effective collaboration, governance, and integration of the patient voice across medical and clinical initiatives.
• Strategic leader with extensive experience building and optimizing Medical Operations systems/process to support Medical Affairs objectives.
• Demonstrated success leading high-performing teams and fostering collaboration across Clinical Development, Medical Affairs, Regulatory Affairs, and Commercial stakeholders.

Qualifications and Experience:

• 10+ years of industry experience in related fields with a concentration in medical operations and 5+ years in a leadership role.
• Scientific degree (PhD, PharmD, MD) or relevant advanced science degree (MS, MPH, MBA).
• Strong attention to detail and project management skills.
• Ability to collaborate effectively with internal stakeholders and external stakeholders.
• Excellent verbal and written communication skills, presentation skills, conflict management, time management and problem-solving skills are required.
• Strong analytical skills and experience with clinical data presentation and interpretation.
• Efficient independent worker with ability to focus and drive for results.
• Ability to work in a fast-paced environment and to handle multiple tasks.
• Strong commitment to compliance and ethical standards.
• High proficiency in Microsoft Word, Excel, PowerPoint, CoPilot, and Outlook.
• Experience with AI preferred.
• Some travel may be required.