Executive Director, Commercial & Medical Systems
Stoke Therapeutics
Summary
Stoke is seeking an experienced, hands-on Executive Director, Commercial & Medical Systems to build and lead the technology foundation for Stoke's first commercial launch. The individual will report to the SVP & Chief Information Officer, lead the Commercial & Medical Systems IT, and be an integral part of the IT leadership team. This leader will own the commercial and medical launch stack and will be the named IT partner to Commercial, Medical Affairs, Patient Services and Market Access as the company prepares for an anticipated early-2028 launch.
Job description
Position Purpose
Stoke is seeking an experienced, hands-on Executive Director, Commercial & Medical Systems to build and lead the technology foundation for Stoke's first commercial launch. The individual will report to the SVP & Chief Information Officer, lead the Commercial & Medical Systems IT, and be an integral part of the IT leadership team. This leader will own the commercial and medical launch stack and will be the named IT partner to Commercial, Medical Affairs, Patient Services and Market Access as the company prepares for an anticipated early-2028 launch.
Key Responsibilities
Roadmap, Strategy and Launch Readiness
- Deliver the technology roadmap for the commercial and medical launch stack, sequenced to the launch plan set by Commercial and Medical Affairs leadership and the build-out of the field organization through 2027.
- Proactively identify platform capabilities and enhancements that support stated business objectives, and partner with functional system owners to translate these opportunities into a prioritized implementation roadmap.
- Support business owners' launch readiness: test environments and test plans for user acceptance testing, system training materials and train-the-trainer, support coverage, escalation paths and contingency plans.
- Run the live stack with ITIL-based incident, change and release management, partnering with vendors and Technology Services on day-to-day support.
- Partner with IT Technology Services on day-one readiness for field hires: devices, access, training and the field support model.
- Plan the post-launch Commercial & Medical Systems IT team and operating model for consideration in future budget cycles.
Platform Implementation & Integration
- Lead the implementation and integration of Salesforce as Stoke's commercial, medical and patient services platform (Sales, Life Sciences and Marketing Cloud).
- Lead the contracting, implementation and integration of the content review (MLR) platform, medical information, field enablement, advisory board, KOL engagement and speaker program platforms, and digital engagement and web platforms.
- Deliver the patient services hub on Salesforce Life Sciences Cloud with the Patient Services team: translate patient journey mapping into hub configuration, case and program workflows, and integrations with specialty pharmacy, benefits verification, copay and pharmacovigilance partners.
- Implement the contact center (CCaaS) platform for voice and text, IVR and skill-based routing, consent-managed recording and adverse event routing to Pharmacovigilance, integrated with Salesforce.
Business Partnership & Governance
- Serve as the accountable IT partner to Commercial Operations, Medical Affairs, Patient Services, Market Access and Trade & Distribution leadership, and to Regulatory Advertising & Promotion and Corporate Communications.
- Translate launch requirements into system capabilities, data flows, budgets and timelines.
- Co-own the commercial and medical systems roadmap, agree priorities and sequencing, and run joint governance through the Commercial IT steering committee.
Data Foundation & Reporting
- Design the commercial and medical data foundation and integrations on which Commercial Operations, Medical Affairs and Patient Services build their reporting and analytics, feeding the enterprise data warehouse.
- Ensure systems capture and make available the complete, standardized data required for business reporting, analytics and downstream applications.
- Partner with business owners to define and validate data completeness, quality and usability as part of system acceptance.
Compliance, Controls & Transparency
- Implement and maintain the system controls that Legal, Compliance and Privacy define for launch systems (including HIPAA and business associate agreements, patient consent and recording retention, TCPA for outbound patient contact, sample accountability where applicable) and SOX/ITGC controls.
- Define and enforce role-based access across systems and reporting, including the separation of commercial and medical users and data in shared platforms.
- Support Compliance and business owners in developing SOPs for commercial and medical systems use ahead of launch.
- Apply Stoke's review process for vendor-embedded AI.
- Deliver the aggregate spend and transparency reporting capability (Open Payments and state laws) with Compliance.
Investment, Budget & Vendor Management
- Manage the Commercial & Medical Systems IT investment plan with business owners: lead business cases and platform evaluations.
- Manage the pillar budget, vendor and implementer performance, license utilization and renewals with Finance, Procurement and Legal.
- Deliver programs through the IT PMO and report status, risks and decisions to the CIO and launch leadership.
Requirements
- Bachelor's degree required; advanced degree a plus
- 15+ years of IT or business systems experience in biopharma
- 8+ years leading commercial and/or medical affairs technology
- Has led the technology build for at least one pharmaceutical or biotech product launch
- Deep knowledge of life sciences commercial platforms, including Salesforce-based CRM for pharma field and medical teams
- Knowledge of content management and MLR review
- Knowledge of medical information and inquiry management
- Knowledge of patient services hub programs (enrollment, benefits verification, copay, case management, specialty pharmacy coordination)
- Knowledge of contact center platforms
- Knowledge of field data and analytics
- Knowledge of digital engagement and web/CMS platforms
- Knowledge of commercial data providers
- Strong understanding of regulatory and compliance environment including HIPAA, consent management, promotional compliance, sample accountability and aggregate spend/transparency reporting
- Demonstrated success managing vendors, implementation partners and multi-year program budgets
- Executive-level communication skills
- Hands-on leader comfortable operating as both strategist and doer in a small, fast-moving team
Benefits
- Medical, Dental & Vision
- Life Insurance
- Long- & Short-Term Disability
- Paid Parental Leave
- 401(k) Matching
- Unlimited PTO
- Tuition Assistance
- ESPP
- Annual Bonus
- Equity Participation
Company overview
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to developing novel RNA-based medicines for severe genetic diseases. Founded in 2014 and headquartered in Bedford, Massachusetts, the company employs its proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach to create antisense oligonucleotides (ASOs) that selectively restore naturally-occurring protein levels. Stoke's innovative platform focuses on haploinsufficiency diseases where patients have approximately 50% of normal protein levels, primarily targeting conditions affecting the central nervous system and eyes. The company's lead investigational medicine, zorevunersen (STK-001), is currently in Phase 3 clinical trials for Dravet syndrome, a severe form of childhood epilepsy, and has demonstrated promising disease-modifying potential. Stoke also has preclinical programs including STK-002 for autosomal dominant optic atrophy. The company has established strategic collaborations with industry leaders like Biogen for Dravet syndrome development and Acadia Pharmaceuticals for neurodevelopmental disorders. With approximately 51-200 employees, Stoke Therapeutics represents a pioneering force in RNA medicine, aiming to address unmet medical needs in rare genetic diseases through its innovative protein restoration technology.