Senior Director, Medical Operations

Job not on LinkedIn

🕒 4 days ago

🇺🇸 United States – Remote

💵 $255k - $295k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Satsuma Pharmaceuticals, Inc.

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11 - 50 employees

Founded 2016

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

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📋 Description

• Lead the operational infrastructure supporting Medical Information, medical review, publication processes, independent medical education, and grants oversight • Establish consistent processes, clear accountability, and high-quality execution across U.S. Medical Affairs activities • Own Medical Affairs system business requirements, design, implementation, and ongoing management in partnership with IT and relevant functions • Integrate workflows, technology, vendor oversight, and performance reporting to support compliant scientific communication and launch readiness • Lead Medical Information operations and workflows supporting publications, independent medical education, grants, and Medical Affairs systems • Partner with Scientific Communications on scientific content and publication strategy • Oversee operational governance, vendor performance, and execution across Medical Affairs • Lead and develop the Medical Affairs operations organization through subordinate managers and team members • Lead Medical Information operating strategy, including inquiry intake, triage, response workflows, service levels, quality review, reporting, and launch readiness • Manage external partners supporting Medical Information, publications, congresses, independent medical education grants, investigator-initiated studies, medical sponsorships, and digital resources • Define scopes, deliverables, budgets, and handoffs • Support recruitment, onboarding, development, and retention of Medical Affairs talent • Establish and oversee the Medical Information delivery model, including resources, training, performance evaluation, and capacity planning • Manage scientific response workflows, approval documentation, distribution, and content updates • Oversee medical congress logistics, booth operations, materials, and staffing coordination • Own Medical Affairs system workflow design, implementation, user testing, training, access roles, data quality, reporting, change control, and support • 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 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 Medical Affairs activities follow company policies and applicable healthcare requirements • Coordinate adverse-event and product-complaint escalation, research governance, scientific engagement controls, and responses to unsolicited medical inquiries • Execute additional responsibilities, initiatives, and special projects as business needs evolve

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, business, law, or a related discipline required • 8+ years of relevant pharmaceutical or biotechnology industry experience, including substantial Medical Affairs operations experience and oversight of Medical Information or related medical programs • Minimum of three years of demonstrated leadership of cross-functional operational teams, including external partner management and organizational capability development • Experience designing, implementing, and managing Medical Affairs systems and workflows, including business requirements, user acceptance testing, training, reporting, and change management in partnership with IT and relevant functions • Experience supporting U.S. product launch readiness • Experience managing Medical Information delivery models and operational workflows supporting medical review, publications, congresses, independent medical education, grants, or investigator-initiated studies • Demonstrated financial and business planning capabilities, including budget development, forecasting, resource allocation, contract oversight, and partner performance management • Strong program management and analytical skills, including development of dashboards, operational metrics, and process improvements • Working knowledge of U.S. requirements and company standards applicable to Medical Affairs activities, scientific exchange, and Medical Information • Strong communication skills and scientific literacy • Neurology or headache experience is preferred • Experience building capabilities in a growing biopharmaceutical organization is highly desirable • Demonstrated integrity, accountability, adaptability, collaborative leadership, and commitment to patients • Demonstrated ability to develop and articulate company-wide Medical Affairs operations strategy, vision, and direction • Proven experience negotiating and influencing 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

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