7 open positions available
Lead and oversee clinical development programs for gene therapies, managing cross-functional teams and ensuring successful trial execution and regulatory compliance. | Minimum 10 years experience in clinical development in biotech/pharma, advanced degree in medicine or life sciences, strong leadership and project management skills, and expertise in gene therapy clinical trials. | 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.
Lead and oversee clinical development programs for gene therapies, ensuring successful trial execution and regulatory compliance. | Minimum 10 years clinical development experience in biotech/pharma, expertise in gene therapy and rare diseases, medical or advanced scientific degree, strong leadership and regulatory knowledge. | 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 cutting-edge technology and a passionate team, we focus on developing innovative gene therapies based on gene-modified hematopoietic stem cells to address unmet medical needs worldwide. Role Overview: As Vice President of Clinical Development, you will play a pivotal role in leading and overseeing clinical programs that drive the advancement of our gene therapy pipeline. Reporting directly to the Chief Medical Officer, you will ensure the successful design, execution, and management of clinical trials to bring life-changing therapies to patients. What You'll Do: - You will lead the clinical development strategy and execution for multiple gene therapy programs. - You will collaborate cross-functionally with research, regulatory, manufacturing, and commercial teams to align clinical objectives. - You will oversee clinical trial design, site selection, patient recruitment, and data analysis. - You will manage relationships with external partners, investigators, and key opinion leaders. - You will ensure compliance with regulatory requirements and ethical standards across all clinical activities. - You will mentor and develop a high-performing clinical development team. - You will contribute to the preparation of clinical sections for regulatory submissions and scientific publications. - You will monitor clinical trial progress and implement risk mitigation 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 development and rare disease landscapes. - You have a proven track record of leading successful clinical trials from early to late phases. - You hold a medical degree (MD) or advanced scientific degree (PhD) with strong clinical expertise. - You demonstrate excellent leadership, communication, and stakeholder management skills. - You are experienced in working with global regulatory agencies and clinical operations. Bonus Points If You Have: - Experience in gene-modified hematopoietic stem cell therapies. - Prior leadership roles in a global clinical development organization. - Familiarity with regulatory submissions in both the US and EU. - Experience collaborating with patient advocacy groups and external research networks. What We Offer: - We offer a dynamic and innovative work environment at the forefront of gene therapy. - We offer competitive compensation and comprehensive benefits including health, dental, and vision insurance. - We offer opportunities for professional growth and leadership development. - We offer flexible work arrangements and support for 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 rare disease treatment.
Lead and oversee clinical development programs for gene therapy, managing teams and partnerships to ensure successful clinical trial execution and regulatory compliance. | Minimum 10 years clinical development experience in biotech/pharma, proven gene therapy program leadership, strong regulatory knowledge, advanced degree preferred, excellent leadership and communication skills. | 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 cutting-edge research and innovative gene-modified hematopoietic stem cell therapies, Orchard Therapeutics is committed to advancing treatments that offer hope and improved outcomes for patients worldwide. Role Overview: As 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 ensure the successful design, execution, and management of clinical trials to bring life-changing therapies to patients. What You'll Do: - You will lead the clinical development strategy and execution for gene therapy programs. - You will manage cross-functional teams to ensure alignment and progress across clinical, regulatory, and commercial functions. - You will oversee clinical trial design, implementation, and data analysis to meet regulatory requirements. - You will collaborate with external partners, investigators, and regulatory agencies to facilitate clinical program success. - 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 efficient program delivery. - You will contribute to the development of regulatory submissions and presentations to key stakeholders. - You will stay abreast of industry trends and scientific advancements to inform clinical strategies. What You Bring: - Minimum of 10 years of clinical development experience in biotechnology or pharmaceutical industries. - Proven track record in leading gene therapy or rare disease clinical programs. - Strong knowledge of regulatory requirements and clinical trial design. - Experience managing cross-functional teams and external partnerships. - Advanced degree in medicine, life sciences, or related field preferred. - Excellent leadership, communication, and strategic planning skills. Bonus Points If You Have: - Experience working in global clinical development environments. - Background in hematopoietic stem cell or gene-modified therapies. - Familiarity with regulatory agencies such as FDA, EMA, and MHRA. - Prior experience in a senior leadership role within a biotech company. What We Offer: - We offer a dynamic and collaborative work environment focused on innovation. - We offer competitive compensation and comprehensive benefits packages. - We offer opportunities for professional growth and 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? To join our team and help transform the future of gene therapy, please submit your resume and cover letter through our careers page at www.orchardtx.com/careers.
Lead and oversee clinical development strategies and clinical trial execution for gene therapy programs. | Minimum 10 years clinical development experience in biotech/pharma, leadership skills, gene therapy knowledge, regulatory expertise, advanced degree preferred. | 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 cutting-edge research and innovative gene-modified hematopoietic stem cell therapies, we strive to deliver life-changing treatments worldwide. Our commitment to scientific excellence and patient care drives our mission to address unmet medical needs. Role Overview: As the Vice President of Clinical Development, you will play a pivotal role in leading and overseeing the clinical development strategy for our gene therapy programs. Reporting directly to the Chief Medical Officer, you will ensure the successful design, execution, and management of clinical trials that advance our pipeline and bring innovative therapies to patients. What You'll Do: - You will lead the clinical development team to design and implement clinical trial strategies aligned with company goals. - You will collaborate with cross-functional teams including regulatory, manufacturing, and commercial to ensure seamless clinical program execution. - You will oversee clinical trial operations, ensuring compliance with regulatory requirements and timelines. - You will manage relationships with external partners, investigators, and key opinion leaders to support clinical development. - You will analyze clinical data to inform decision-making and optimize development pathways. - You will contribute to regulatory submissions and interactions with health authorities. - You will mentor and develop clinical development staff to build a high-performing team. - You will stay abreast of industry trends and scientific advancements to guide strategic planning. What You Bring: - Minimum of 10 years of experience in clinical development within the biotechnology or pharmaceutical industry. - Proven leadership experience managing clinical teams and complex clinical programs. - Strong knowledge of gene therapy development and rare disease clinical trial design. - Expertise in regulatory requirements and clinical trial compliance. - Excellent communication and interpersonal skills to collaborate effectively across teams. - Advanced degree in medicine, life sciences, or related field preferred. Bonus Points If You Have: - Experience working in gene therapy or rare disease-focused companies. - Track record of successful regulatory submissions and approvals. - International clinical development experience, particularly in the US and EU. - Experience with hematopoietic stem cell gene-modified therapies. What We Offer: - We offer a dynamic and innovative work environment at the forefront of gene therapy. - 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 patient lives through gene therapy.
Lead and oversee clinical development strategy and execution for gene therapy programs, managing teams and stakeholder relationships to ensure successful clinical outcomes. | At least 10 years of clinical development experience in biotech/pharma, strong gene therapy background, advanced degree, leadership skills, and regulatory knowledge. | 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 genetic disorders. With cutting-edge technology and a passionate team, we focus on developing innovative gene therapies based on gene-modified hematopoietic stem cells to deliver lasting solutions. Role Overview: As Vice President of Clinical Development, you will lead and oversee the clinical development strategy and execution for our gene therapy programs. Reporting directly to the Chief Medical Officer, you will play a critical role in advancing our pipeline and ensuring successful clinical outcomes. What You'll Do: - You will develop and implement clinical development plans aligned with company goals and regulatory requirements. - You will lead cross-functional teams to design and execute clinical trials for gene therapy products. - You will manage relationships with key stakeholders including regulatory agencies, investigators, and partners. - You will oversee clinical data analysis and reporting to support regulatory submissions. - You will ensure compliance with GCP and other relevant guidelines throughout clinical development. - You will mentor and develop clinical development staff to build a high-performing team. - You will collaborate with commercial and manufacturing teams to align clinical strategies with product launch plans. - You will monitor clinical trial progress and budgets, addressing challenges proactively. What You Bring: - You bring at least 10 years of clinical development experience in biotechnology or pharmaceutical industries. - You have a strong background in gene therapy or rare diseases clinical programs. - You possess deep knowledge of regulatory requirements and clinical trial design. - You have proven leadership skills managing cross-functional teams and external partnerships. - You hold an advanced degree in medicine, life sciences, or a related field. - You demonstrate excellent communication and strategic thinking abilities. Bonus Points If You Have: - Experience working in global clinical development environments. - Prior leadership roles in gene therapy or rare disease companies. - Familiarity with hematopoietic stem cell gene modification technologies. - Track record of successful regulatory submissions and product approvals. What We Offer: - We offer a dynamic and innovative work environment at the forefront of gene therapy. - We offer competitive compensation and comprehensive benefits packages. - We offer opportunities for professional growth and leadership development. - We offer flexible work arrangements including options for remote work. - We offer a collaborative culture committed to patient impact and scientific excellence. 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 transforming patient lives with Orchard Therapeutics.
Lead and oversee clinical development strategy and execution for gene therapy programs, managing teams and regulatory interactions to advance therapies from development to approval. | Minimum 10 years clinical development experience in biopharma or gene therapy, leadership skills, knowledge of gene therapy and regulatory agencies, advanced degree preferred. | 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 strategy and execution for Orchard Therapeutics' gene therapy programs. Reporting directly to the Chief Medical Officer, you will drive clinical innovation and ensure the successful advancement of therapies from early development through regulatory approval. What You'll Do: - You will lead the design and implementation of clinical development plans for gene therapy programs. - You will manage cross-functional teams to ensure alignment and successful execution of clinical trials. - You will collaborate with regulatory agencies to facilitate approvals and compliance. - You will oversee clinical data analysis and reporting to support decision-making. - You will build and maintain relationships with key opinion leaders and external partners. - You will contribute to strategic planning and portfolio management. - You will mentor and develop clinical development staff to foster growth and excellence. - You will ensure adherence to ethical standards and regulatory requirements in all clinical activities. What You Bring: - Minimum of 10 years of clinical development experience in the biopharmaceutical or gene therapy industry. - Proven leadership experience managing clinical teams and complex clinical programs. - Strong knowledge of gene therapy development, hematopoietic stem cell biology, and rare disease clinical trials. - Experience working with regulatory agencies such as FDA and EMA. - Excellent communication, strategic thinking, and problem-solving skills. - Advanced degree in medicine, life sciences, or related field preferred. Bonus Points If You Have: - Experience in global clinical development across multiple regions. - Background in hematology or genetic disorders. - Track record of successful regulatory submissions and approvals. - Experience in partnering with external research organizations and industry collaborators. What We Offer: - We offer a dynamic and collaborative work environment focused on innovation and patient impact. - We offer competitive salary and comprehensive benefits including health, dental, and vision coverage. - We offer opportunities for professional growth and leadership development. - We offer flexible work arrangements to support work-life balance. - We offer the chance to be part of a mission-driven company making a real difference in rare disease treatment. 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 patient lives through gene therapy.
Lead and manage clinical development programs for gene therapy products, ensuring regulatory compliance and successful trial execution. | Minimum 10 years clinical development experience in biotech/pharma, advanced degree in relevant field, strong leadership and project management skills. | 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.