Orchard Therapeutics

Title: Senior Manager, PV Operations Location: London England GB\ Full time Job Description: Location: London, UK / Hybrid Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. Job Summary: The Senior Manager, PV Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. This role on a day to day basis ensures the seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post-marketing portfolios. This role serves as the primary operational interface for PV vendors and cross‑functional study teams. The Senior Manager, PV Operations is an emerging expert who translates the functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures that the "hands‑on" elements of the PV system are robust, scalable, and inspection‑ready. Key Elements and Responsibilities: - Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies with close oversight of the pharmacovigilance vendors. - Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources. Act as database business administrator for the Orchard safety database (Veeva Safety). - Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics. - Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Vendor Safety Systems teams. - Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations. - Act as key technical SME supporting inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans. - Liaise with Orchard Quality Assurance colleagues to ensure audit programme of internal and external components of the pharmacovigilance system and partners run smoothly - Collaborate with safety physician, safety scientist and cross-functional teams to ensure efficient processes and systems for production of high-quality data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs). - Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks. - Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows. Requirements Education, Experience & Knowledge Education - Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field. - Relevant certifications in pharmacovigilance or drug safety are highly desirable. Experience - Extensive experience in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting. - Experience with safety databases (Veeva Safety preferred but not required) - In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally. - Strong experience with safety databases and PV systems, including configuration, validation, and maintenance. - Demonstrated ability to lead and oversee PV vendors/CROs. - Experience with clinical studies, postmarketing safety, risk management plans and aggregate report preparation. - Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills. Desirable - Advanced degree in a relevant scientific or health-related field. - Experience with safety data exchange agreements (SDEAs) and literature surveillance. - Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations. - Demonstrated understanding of clinical development processes. - Experience with global product launches and implementation/assessment of complex risk minimisation measures. - Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety). Skills & Abilities · Self-motivated, with initiative and ability to take ownership of, and follow through with, specific tasks · Working knowledge of available information sources and ability to navigate multiple channels to secure required information · Works effectively with cross-functional teams to address complex issues and recommend actions with potentially significance impact · Effective time management and organization skills · Ability to multi-task and shift priorities quickly while working under tight deadlines · Excellent verbal and written communication skills · Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel and Powerpoint)

• 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.

• 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

Role Description The Senior Medical Science Liaison (Sr MSL) is a therapeutic and disease area scientific expert for investigational and approved gene therapy clinical programs. They demonstrate leadership in field medical excellence and coaching as well as medical and scientific support with national level strategic planning in the Eastern Territory of the United States. As a field-based member of the medical affairs team, the Sr MSL will be responsible for developing and enhancing professional relationships with external thought leaders involved in all phases of the clinical development process through a fair-balanced and high-value exchange of clinical and scientific information. In addition to these typical MSL responsibilities, the Sr MSL will develop strategy, serve as a team mentor, and lead national level initiatives. Key Responsibilities - 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. - 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. - 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. - 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. - 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. - Monitor the competitive environment for advances and trends in the therapeutic area. - Serve as peer leader to mentor and coach new or junior MSLs, supporting onboarding, training, and field excellence. Qualifications - Advanced Scientific / Healthcare Degree (PhD, PharmD, MD, NP, DVM, CGC or similar preferred; RN, MS, or similar with substantial experience considered). - Minimum of 5 years of experience in a scientific, clinical or MSL role within the biotech or pharmaceutical industry. - Extensive experience as an MSL supporting post-approval commercial products in the field. - Ability to lead and motivate team members without a direct reporting relationship. - Track record of successfully establishing relationships with health care provider thought leaders. - Understanding of US government and industry guidelines, regulations, laws, etc. - Experience and relevant knowledge in one or more key therapeutic areas: hematopoietic stem cell transplantation, gene therapy, and neurology/genetics. - Experience in developing and delivering effective scientific educational materials and programs. - Strong knowledge and established network with health care providers and industry experts. - Fluency in both spoken and written English. - Excellent communication and presentation skills. - Effective interpersonal skills and awareness of inward and outward emotional intelligence. - Ability to apply technical expertise and solutions to diverse/individualized situations. - Experience in achieving results, generating ideas and influencing outcomes through collaboration. - Highly effective in building close working relationships with cross-functional partners. - Growth mindset – curious by nature, proactive in keeping abreast of key scientific developments. - Valid US Driver’s License and clean driving record. - Ability to travel frequently (75%), often overnight. Salary Range The anticipated salary for this position will be $170,000 - $225,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education, job-based knowledge, location, and other business and organizational needs. Company Description Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.

• 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.

Location: Remote, Central Territory US         Reporting to: Senior Director, Medical Affairs – Americas                 Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts. Job Summary The Medical Science Liaison (MSL) is a therapeutic and disease area scientific expert for investigational and approved gene therapy clinical programs. As a field-based member of the medical affairs team, the MSL will be responsible for developing and enhancing professional relationships with external thought leaders involved in all phases of the clinical development process through a fair-balanced and high-value exchange of clinical and scientific information. This position necessitates professionals exhibiting established personal and scientific credibility and self-awareness, who work well in a collaborative, cross-functional environment with other individuals within broader US and Global organization.     Key Responsibilities ·         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.