Orchard Therapeutics

Clinical Operations

• **Key Elements and Responsibilities**
• · Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
• · Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
• · Drive cross-functional collaboration to deliver clinical trials on time and within budget.
• · Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
• · Act as the primary escalation point for critical study and vendor issues.
• · Oversee study budgets, timelines, resources, and financial tracking.
• · Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of:
• o Clinical documentation
• o Data management activities
• · Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
• · Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
• · Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
• · Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
• · Build and maintain strong relationships with investigators and key opinion leaders.
• · Lead, develop, and mentor high-performing teams.
• · Ensure delivery of high-quality study documentation to meet program timelines.

VP, Clinical Operations, Data Management

Operations

• Develop trusted relationships with qualified treatment centers (QTC’s), healthcare professionals and patient organizations
• Supporting the QTC in Utrecht, The Netherland and coordinating patient’s treatment ensuring that it adheres to what is described in the Product Manual and facilitating the exchange of the related mandatory documentation with Orchard’s Supply Chain Team
• In partnership with the Medical Director, engage disease experts via advisory boards and individual interactions to accelerate patient identification and diagnosis
• Oversee the development of disease-related and product-related materials and their approval for use in the Benelux, in partnership with the Medical Director
• Drive disease awareness and the identification of potential patient candidates for treatment with Libmeldy® and other Orchard gene therapies
• Resolve issues of access to treatment by potential patient candidates to gene therapy, in collaboration with the Market Access function
• Plan activities and track budget in the franchise
• Role-model corporate values and behaviours; foster compliance with legal and regulatory requirements and corporate SOPs, and the pursuit of the highest ethical standards
• Performs other tasks and assignments as needed and specified by management. regarding the strategy and operations in the neurometabolic franchise
• Represent Orchard during meetings and congresses.

Therapeutic Operations Lead

Therapist

• Identify, build and maintain collaborative partnerships with healthcare providers (HCP’s) and key external experts such as KOL’s and academic institutions to become a trusted scientific partner.
• Provide timely, audience-appropriate information and updates to enhance the understanding of the scientific and medical value of Orchard’s programs. This includes, but is not limited to, collaboration with Market Access, Government Affairs, Diagnostics, Patient Advocacy, Clinical Development etc.
• Maintain training records and deliver training updates to ensure all personnel in assigned Qualified Treatment Centers are appropriately trained according to Orchard’s SOPs and the latest Product Manual.
• Develop a territory profile including Centers of Excellence, key expertise, newborn screening approaches and leaders, and market access pathways to inform medical strategy and tactical planning in collaboration with our Commercial, Diagnostic, and Patient Advocacy partners.
• Gather insights from the field on data, therapeutic area, and competitive intelligence to help inform company strategies and evidence generation plans.
• Build thorough operational understanding to ensure excellence in execution balanced with risk management within the boundaries of all governance processes.
• Review and oversee Investigator-Sponsored Trial (IST) requests and Early Access Program (EAP) requests throughout the internal review process and any follow up requests for information.
• Build effective internal partnerships through communication and collaboration across the organization with individuals from Medical Affairs, Patient Advocacy, Public Affairs, Clinical Development, Clinical Operations, Technical Operations, Market Access, Commercial, etc.
• Ensure compliance with internal and external regulatory and legal guidelines.
• Maintain clinical, scientific, and technical expertise in therapeutic area.
• Develop strategic initiatives to support departmental goals from a field medical excellence perspective
• Successfully manage at least two large cross-functional projects with demonstrated leadership and collaboration skills while successfully maintaining geographical responsibilities
• Proactively seek out and demonstrate successful peer coaching of other team members
• Develop US field resource materials specific to stakeholder group, disease state, and technology.
• Provide strategic insights by maintaining expertise in the therapeutic area and related fields to effectively communicate scientific insights and support strategic objectives
• Monitor the competitive environment for advances and trends in the therapeutic area, including new treatment management and therapies, competitive products and provide feedback to internal stakeholders on specific initiatives of competitors
• Serves as peer leader to mentor and coach new or junior MSLs, supporting onboarding, training, and field excellence

VP, Clinical Operations, Data Management

Therapeutic Operations Lead

Senior Medical Science Liaison – Gene Therapy