Orchard Therapeutics

Compensation

Full Description

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 therapies based on gene-modified hematopoietic stem cells, 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. Reporting directly to the Chief Medical Officer, you will be responsible for strategic planning, execution, and management of clinical trials to ensure successful development and regulatory approval of novel gene therapies. What You'll Do: - You will lead the design and implementation of clinical development strategies for gene therapy programs. - You will manage cross-functional teams including clinical operations, regulatory affairs, and medical affairs to ensure alignment and successful trial execution. - You will oversee clinical trial protocols, patient recruitment, and data analysis to meet regulatory standards. - You will collaborate with external partners, investigators, and regulatory agencies to facilitate clinical development. - You will provide leadership and mentorship to clinical development staff, fostering a culture of innovation and excellence. - You will monitor clinical trial progress, budgets, and timelines to ensure project milestones are met. - You will contribute to the preparation of regulatory submissions and scientific publications. - You will stay abreast of industry trends and emerging technologies to inform clinical development strategies. 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. - You are experienced in working with global teams and regulatory bodies. Bonus Points If You Have: - Experience specifically in gene-modified hematopoietic stem cell therapies. - Prior leadership roles in a global biotech or gene therapy company. - Familiarity with regulatory submissions to FDA, EMA, and other global agencies. - A network of key opinion leaders and clinical investigators in rare diseases. What We Offer: - We offer a dynamic and collaborative work environment at the forefront of gene therapy innovation. - We offer competitive compensation and comprehensive benefits including health, dental, and vision insurance. - We offer opportunities for professional growth and development in a rapidly evolving industry. - 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.