Senior Director, Medical Operations

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

📋 Description

• Oversee the operational framework that supports Medical Information, medical review, publication processes, independent medical education, and grants management.

• Implement standardized processes, define clear responsibilities, and ensure high-quality execution across U.S. Medical Affairs initiatives.

• Manage business requirements, design, implementation, and ongoing administration of Medical Affairs systems in collaboration with IT and relevant departments.

• Streamline workflows, technology integration, vendor oversight, and performance reporting to facilitate compliant scientific communication and launch preparation.

• Direct Medical Information operations and workflows that support publications, independent medical education, grants, and Medical Affairs systems.

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

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

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

• Formulate the operating strategy for Medical Information, which includes inquiry intake, triage, response workflows, service levels, quality assessments, reporting, and launch preparedness.

• Oversee external partnerships related to Medical Information, publications, congresses, independent medical education grants, investigator-initiated studies, medical sponsorships, and digital assets.

• Define project scopes, deliverables, budgets, and transitions.

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

• Establish and manage the Medical Information delivery framework, encompassing resources, training, performance evaluation, and capacity planning.

• Supervise scientific response workflows, approval documentation, distribution, and content revisions.

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

• Oversee the design, implementation, user testing, training, access roles, data integrity, reporting, change control, and support of Medical Affairs systems.

• Create and manage workflows, documentation, and tracking for scientific medical reviews, promotional assessments, and external review committees.

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

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

• Maintain budget forecasts, vendor performance metrics, launch timelines, and operational risk reports.

• Ensure compliance of Medical Affairs activities with company policies and applicable 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 evolve.

⛳️ Requirements

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

• A minimum of 8 years of relevant experience in the pharmaceutical or biotechnology industry, with significant Medical Affairs operations experience and oversight of Medical Information or related medical programs.

• At least three years of proven leadership in managing cross-functional operational teams, including management of external partners and development of organizational capabilities.

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

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

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

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

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

• Working knowledge of U.S. requirements and company standards relevant to Medical Affairs activities, scientific exchange, and Medical Information.

• Excellent communication skills and a strong scientific background.

• Experience in neurology or headache management is preferred.

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

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

• Proven ability to develop and communicate a comprehensive Medical Affairs operations strategy, vision, and direction across the company.

• Established experience in negotiation 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