Senior Director, Medical Operations

Satsuma Pharmaceuticals, Inc.; United States; On-site; USD 255,000 - 295,000; Full time

Benefits offered by this job

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

Job summary

Satsuma Pharmaceuticals is seeking a Senior Director of Medical Operations to lead the operations backbone of Medical Information, medical review, publications, independent medical education, and grants oversight in support of AtzumiTM launch readiness in the United States.

You will own the design and ongoing management of Medical Affairs systems, partner with IT and other functions, and drive compliant scientific communication and performance reporting across Medical Affairs activities.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 8+ years in pharma/biotech with Medical Affairs operations experience.
• 3+ years leading cross-functional teams and external partners.
• Experience designing and managing Medical Affairs systems/workflows with IT.
• Experience supporting US product launch readiness and launch infrastructure.
• Experience managing Medical Information delivery models and workflows.
• Financial and business planning experience including budgets and forecasting.
• Strong program management, analytics, and process improvement skills.
• Working knowledge of US Medical Affairs requirements and standards.
• Strong communication, scientific literacy, and cross-functional collaboration.
• Neurology/headache experience preferred.
• Demonstrated integrity, accountability, adaptability, collaboration.
• Ability to develop and articulate organization-wide Medical Affairs strategy.

Responsibilities

• Lead Medical Information ops and workflows for publications, education, grants, and systems.
• Partner with Scientific Communications on content strategy and governance.
• Develop and lead Medical Affairs operations organization and leadership.
• Own Medical Information strategy: inquiry intake, triage, responses, and launch readiness.
• Provide strategic direction to ensure compliance and business success.
• Manage external partners; define scopes, budgets, and handoffs.
• Support recruitment, onboarding, and development of Medical Affairs talent.
• Establish and manage delivery model, training, and capacity planning.
• Oversee scientific review workflows and content accuracy with key stakeholders.
• Coordinate congress logistics and field leadership engagement planning.
• Oversee system requirements, testing, training, data quality, and change control.
• Manage documentation for review committees and medical input coordination.
• Align priorities with VP Medical Affairs and other functions.
• Cascade company-wide Medical Affairs policies and SOPs; monitor budgets and milestones.
• Ensure compliance with healthcare regulations and escalation procedures.
• Identify and lead additional responsibilities as business needs evolve.

Skills

Leadership

Cross-functional leadership

Program management

Strategic planning

Financial planning

Stakeholder management

Medical Affairs knowledge

US regulatory knowledge

Medical information delivery

Communication

Neurology/headache experience

Integrity and accountability

Executive-level negotiation

Education

Bachelor’s degree in life sciences / healthcare / business

Advanced degree preferred (PharmD/PhD/MD/MS/MBA/JD)

Job description

Satsuma Pharmaceuticals is a biopharmaceutical company preparing to launch AtzumiTM (dihydroergotamine (DHE) nasal powder), a novel therapeutic product approved in the US for the acute treatment of migraine. AtzumiTM incorporates proprietary advanced powder and device technology (SMART – Simple MucoAdhesive Release Technology™) and is designed to be easy-to-use, easy-to-carry and for quick self-administration.

Position Summary:

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.

Key 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.

Minimum Requirements Education/Experience:

• Bachelor’s degree in life sciences, healthcare, business, law, or a related discipline required. An advanced degree, including PharmD, PhD, MD, MS, MBA, or Juris Doctor (JD), is preferred.
• 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.
• 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, 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.

Benefits and Pay:

The expected salary range for this position is $255,000.00 - $295,000.00 USD. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.

Satsuma Pharmaceuticals is committed to providing its employees with benefit options that are comprehensive, competitive, and that individual employees can tailor to their and their families’ specific needs. Eligible employees are offered 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, and Company Holidays.

EEO & Employment Eligibility:

Satsuma Pharmaceuticals is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Satsuma Pharmaceuticals also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.