Orchard Therapeutics

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Job Title: Vice President, Clinical Development Company Overview: Orchard Therapeutics, a Kyowa Kirin company, is a global leader in gene therapy dedicated to transforming the lives of patients with rare disorders. With a strong focus on innovative gene-modified hematopoietic stem cell therapies, Orchard Therapeutics is committed to advancing cutting-edge treatments that address unmet medical needs worldwide. Role Overview: As the Vice President of Clinical Development, you will play a pivotal role in leading and overseeing the clinical development programs that drive Orchard Therapeutics' mission forward. You will collaborate closely with cross-functional teams to design and execute clinical strategies that ensure the successful development and approval of novel gene therapies. What You'll Do: - You will lead the clinical development team to design, implement, and manage clinical trials for gene therapy products. - You will collaborate with regulatory agencies to ensure compliance and facilitate timely approvals. - You will develop clinical strategies aligned with company goals and scientific advancements. - You will oversee data analysis and interpretation to guide clinical decision-making. - You will manage relationships with key stakeholders including investigators, partners, and vendors. - You will provide leadership and mentorship to clinical development staff. - You will contribute to the preparation of clinical study reports and regulatory submissions. - You will monitor clinical trial progress and implement corrective actions as needed. What You Bring: - You have at least 10 years of experience in clinical development within the biotechnology or pharmaceutical industry. - You possess deep knowledge of gene therapy clinical trial design and regulatory requirements. - You have a proven track record of leading successful clinical programs from early development through approval. - You hold an advanced degree in medicine, life sciences, or a related field. - You demonstrate strong leadership, communication, and project management skills. Bonus Points If You Have: - Experience working in rare diseases or gene therapy specifically. - Familiarity with global regulatory environments including FDA and EMA. - Experience managing cross-functional teams in a fast-paced environment. - Prior experience in a senior leadership role within a biotech company. What We Offer: - We offer a dynamic and innovative work environment focused on cutting-edge gene therapy research. - We offer competitive compensation and comprehensive benefits packages. - We offer opportunities for professional growth and leadership development. - We offer flexible work arrangements to support work-life balance. - We offer the chance to make a meaningful impact on patients' lives worldwide. Ready to Apply? Please submit your resume and cover letter through our careers page at www.orchardtx.com/careers. We look forward to learning how you can contribute to our mission of transforming lives through gene therapy.