Senior Director, Medical Operations

Satsuma Pharmaceuticals

3d•$255,000 - $295,000

About The Position

The Senior Director, Medical Operations, will lead the operational infrastructure supporting Medical Information, medical review, publication processes, independent medical education, and grants oversight. This leadership role will establish consistent processes, clear accountability, and high-quality execution across Satsuma’s U.S. Medical Affairs activities. The position will own the business requirements, design, implementation, and ongoing management of Medical Affairs systems in partnership with IT and relevant functions. Working closely with Scientific Communications and field medical leadership, the Senior Director will integrate workflows, technology, vendor oversight, and performance reporting to support compliant scientific communication and launch readiness. The successful candidate develops and provides Medical Affairs operations strategy, vision, and direction across the organization, cascading company-wide policies and practices and providing input to executive management, with decisions carrying long-term impact on the company’s launch readiness and market success.

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.
Demonstrated 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, preferably including establishment or expansion of Medical Affairs infrastructure.
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, scientific literacy, and ability to collaborate with scientific content owners and influence cross-functional stakeholders.
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, with the ability to anticipate emerging risks and their impact on business success.
Proven experience negotiating and influencing at the executive level, partnering with leadership to align Medical Affairs operations strategy with organizational goals.

Nice To Haves

An advanced degree, including PharmD, PhD, MD, MS, MBA, or Juris Doctor (JD), is preferred.
Neurology or headache experience is preferred.
Experience building capabilities in a growing biopharmaceutical organization is highly desirable.

Responsibilities

Lead Medical Information operations and the workflows supporting publications, independent medical education, grants, and Medical Affairs systems.
Partner with Scientific Communications on scientific content and publication strategy, and oversee operational governance, vendor performance, and execution across Medical Affairs.
Lead and develop the Medical Affairs operations organization through subordinate managers and team members, overseeing the successful execution of company-wide initiatives.
Lead the Medical Information operating strategy, including inquiry intake, triage, response workflows, service levels, quality review, reporting, and launch readiness.
Anticipate factors that could influence the company’s Medical Affairs operations strategy and market position, providing strategic direction across functional areas to support long-term compliance and business success.
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 to prevent duplicated work.
Support recruitment, onboarding, development, and retention of Medical Affairs talent in partnership with functional leaders and Human Resources.
Establish and oversee the Medical Information delivery model, including internal and external resources, training, performance evaluation, and capacity planning.
Manage scientific response workflows, approval documentation, distribution, and content updates. Partner with Scientific Communications and designated medical reviewers on scientific content development and accuracy.
Oversee medical congress logistics, booth operations, materials, and staffing coordination. Partner with Scientific Communications on content and field medical leadership on engagement planning.
Own Medical Affairs system requirements, workflow design, implementation, and ongoing management in partnership with IT and Quality. Oversee 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. Provide medical input within assigned responsibilities and delegated authority.
Partner with the VP, Medical Affairs, field medical, Scientific Communications, HEOR, Regulatory, Safety, Quality, Legal, Compliance, and IT to align operational priorities and execution.
Partner with executive leadership to cascade company-wide Medical Affairs operations policies and practices, ensuring consistent adoption and alignment with organizational goals.
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 with accountable functions.
Proactively identify, assume, and execute additional responsibilities, initiatives, and special projects as business needs evolve.