Senior Director, Medical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the operational framework that supports Medical Information, medical reviews, publication processes, independent medical education, and grants oversight.

• Create standardized processes, clear accountability, and ensure high-quality execution across U.S. Medical Affairs activities.

• Manage Medical Affairs system business requirements, including design, implementation, and continuous management in collaboration with IT and relevant departments.

• Integrate workflows, technology, vendor management, and performance reporting to facilitate compliant scientific communication and readiness for product launches.

• Supervise Medical Information operations and workflows related to publications, independent medical education, grants, and Medical Affairs systems.

• Collaborate with Scientific Communications on scientific content and publication strategies.

• Oversee operational governance, vendor performance, and execution across Medical Affairs.

• Lead and nurture the Medical Affairs operations team through subordinate managers and team members.

• Direct the Medical Information operational strategy, including inquiry intake, triage, response workflows, service levels, quality review, reporting, and readiness for launches.

• Manage external partners involved in Medical Information, publications, congresses, independent medical education grants, investigator-initiated studies, medical sponsorships, and digital resources.

• Define scopes, deliverables, budgets, and transitions.

• Assist in the recruitment, onboarding, development, and retention of Medical Affairs talent.

• Establish and supervise the Medical Information delivery model, which includes resources, training, performance evaluation, and capacity planning.

• Manage scientific response workflows, approval documentation, distribution, and content updates.

• Oversee logistics for medical congresses, booth operations, materials, and staffing coordination.

• Take charge of the design, implementation, user testing, training, access roles, data quality, reporting, change control, and support for Medical Affairs system workflows.

• Establish and manage workflows, documentation, and tracking for scientific medical review, promotional review, and external review committees.

• Partner with Medical Affairs, field medical, Scientific Communications, HEOR, Regulatory, Safety, Quality, Legal, Compliance, and IT stakeholders.

• Lead the development, approval coordination, implementation, training, and periodic review of Medical Affairs SOPs, standards, and policies.

• Maintain budget forecasts, vendor performance metrics, launch milestones, and operational risk reporting.

• Ensure that Medical Affairs activities comply with company policies and relevant healthcare regulations.

• Coordinate the escalation of adverse events and product complaints, research governance, scientific engagement controls, and responses to unsolicited medical inquiries.

• Execute additional responsibilities, initiatives, and special projects as business needs change.

⛳️ Requirements

• A Bachelor's degree in life sciences, healthcare, business, law, or a related field is required.

• 8+ years of pertinent experience in the pharmaceutical or biotechnology industry, including significant Medical Affairs operations experience and oversight of Medical Information or related medical programs.

• A minimum of three years of proven leadership in managing cross-functional operational teams, including external partner management and the development of organizational capabilities.

• Experience in designing, implementing, and managing Medical Affairs systems and workflows, encompassing business requirements, user acceptance testing, training, reporting, and change management with IT and relevant functions.

• Proven experience in supporting U.S. product launch readiness.

• Experience in managing Medical Information delivery models and operational workflows that support medical reviews, publications, congresses, independent medical education, grants, or investigator-initiated studies.

• Demonstrated financial and business planning skills, including budget development, forecasting, resource allocation, contract oversight, and partner performance management.

• Strong program management and analytical abilities, including the development of dashboards, operational metrics, and process enhancements.

• A working knowledge of U.S. requirements and company standards applicable to Medical Affairs activities, scientific exchange, and Medical Information.

• Exceptional communication skills and scientific literacy.

• Experience in neurology or headache is preferred.

• Experience in building capabilities within a growing biopharmaceutical organization is highly desirable.

• Proven integrity, accountability, adaptability, collaborative leadership, and a commitment to patient care.

• Demonstrated ability to develop and communicate a company-wide Medical Affairs operations strategy, vision, and direction.

• Proven ability to negotiate and influence at the executive level.

🏝️ Benefits

• Health Insurance

• Dental & Vision Insurance

• Healthcare & Dependent Care FSA

• Employee Assistance Program (EAP)

• 401(k) Savings Plan

• Long-term Incentive Plan

• Life Insurance

• Accident & Disability Insurance

• Telemedicine

• Generous Paid Time Off

• Company Holidays