14 open positions available
Lead and oversee clinical development strategy and execution for gene therapy programs, managing cross-functional teams and regulatory interactions. | Minimum 10 years clinical development experience in biotech/pharma, advanced degree, strong leadership and regulatory knowledge, gene therapy expertise. | 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 the clinical development strategy and execution for our 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 products. - You will manage cross-functional teams including clinical operations, regulatory affairs, and medical affairs to ensure alignment and successful program execution. - You will oversee clinical trial design, site selection, and patient recruitment strategies. - You will collaborate with regulatory agencies to facilitate approvals and ensure compliance with global regulations. - You will analyze clinical data to inform decision-making and optimize development pathways. - You will mentor and develop clinical development staff to build a high-performing team. - You will represent Orchard Therapeutics at scientific conferences and industry meetings. - You will contribute to strategic planning and budgeting for clinical development programs. 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 development and rare disease clinical programs. - You have a proven track record of leading successful clinical trials from early phase to registration. - You hold an advanced degree in medicine, life sciences, or a related field. - You demonstrate strong leadership, communication, and project management skills. - You have experience working with global regulatory agencies and navigating complex regulatory environments. Bonus Points If You Have: - Experience in hematopoietic stem cell gene therapy development. - Prior leadership roles in a gene therapy or rare disease-focused company. - Familiarity with both US and European regulatory frameworks. - A network of relationships within the gene therapy clinical development community. 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 lives through gene therapy.
Lead and oversee clinical development programs for gene therapies, ensuring successful trial design, execution, and regulatory compliance. | Minimum 10 years clinical development experience in biotech/pharma, expertise in gene therapy, leadership skills, advanced degree in medicine or life sciences. | 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 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, and commercial teams to align clinical objectives. - You will oversee clinical trial design, site selection, and patient recruitment to ensure timely and efficient study progress. - You will manage relationships with external partners, investigators, and key opinion leaders. - You will ensure compliance with regulatory requirements and maintain high standards of clinical data integrity. - You will mentor and develop clinical development teams to foster a culture of excellence and innovation. - You will contribute to the preparation of clinical sections for regulatory submissions and scientific publications. - You will monitor clinical trial budgets and timelines to optimize resource allocation. 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 regulatory pathways. - You have a proven track record of leading successful clinical trials from early to late phases. - You demonstrate strong leadership skills with experience managing multidisciplinary teams. - You hold an advanced degree in medicine, life sciences, or a related field. - You have excellent communication and interpersonal skills to engage effectively with internal and external stakeholders. Bonus Points If You Have: - Experience working in rare diseases or gene therapy-focused companies. - Familiarity with global regulatory agencies including FDA, EMA, and MHRA. - Background in hematopoietic stem cell transplantation or related therapeutic areas. - Experience in strategic planning and business development within clinical development. What We Offer: - We offer a dynamic and collaborative work environment committed to innovation and patient impact. - We offer competitive compensation 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 pioneering company transforming rare disease treatment. Ready to Apply? To join our team and help shape the future of gene therapy, please submit your resume and cover letter through our careers page at www.orchardtx.com/careers. We look forward to hearing from you!
Lead and oversee clinical development programs for gene therapies targeting rare disorders, ensuring regulatory compliance and successful trial execution. | Minimum 10 years clinical development experience in biopharma or gene therapy, strong leadership and regulatory knowledge, advanced degree in medicine or life sciences. | 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. Our commitment to scientific excellence and patient care drives us to pioneer treatments that offer hope and improved outcomes 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. Reporting directly to the Chief Medical Officer, you will guide cross-functional teams to advance our gene therapy pipeline from early clinical stages through regulatory approval, ensuring the highest standards of clinical excellence and patient safety. What You'll Do: - You will lead the design, planning, and execution of clinical development programs for gene therapies targeting rare disorders. - You will collaborate with internal teams and external partners to ensure alignment on clinical objectives and regulatory strategies. - You will oversee clinical trial operations, including site selection, patient recruitment, and data integrity. - You will manage clinical development budgets and timelines to meet organizational goals. - You will provide leadership and mentorship to clinical development teams, fostering a culture of innovation and accountability. - You will engage with regulatory authorities to facilitate approvals and ensure compliance with global regulations. - You will analyze clinical data to inform decision-making and support product lifecycle management. - You will represent Orchard Therapeutics at scientific conferences and industry forums to enhance the company’s visibility. What You Bring: - Minimum of 10 years of clinical development experience in the biopharmaceutical or gene therapy industry. - Proven track record of leading successful clinical programs, preferably in rare diseases or gene therapy. - Strong knowledge of regulatory requirements and clinical trial design. - Excellent leadership, communication, and interpersonal skills. - Advanced degree in medicine, life sciences, or related field (MD, PhD, or equivalent). - Experience working in a global, cross-functional environment. Bonus Points If You Have: - Experience with gene-modified hematopoietic stem cell therapies. - Prior leadership role in a gene therapy or rare disease company. - Familiarity with both US and EU regulatory landscapes. - Published scientific research or presentations at major conferences. What We Offer: - We offer a dynamic and collaborative work environment committed to innovation and patient impact. - We offer competitive compensation and comprehensive benefits including health, dental, and vision insurance. - We offer opportunities for professional growth and development within a global leader in gene therapy. - 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 patients’ lives. 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 targeting rare disorders, ensuring regulatory compliance and successful trial execution. | Minimum 10 years clinical development experience in biopharma or gene therapy, strong leadership and regulatory knowledge, advanced degree in medicine or life sciences. | 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. Our commitment to scientific excellence and patient care drives us to pioneer treatments that offer hope and improved outcomes 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. Reporting directly to the Chief Medical Officer, you will guide cross-functional teams to advance our gene therapy pipeline from early clinical stages through regulatory approval, ensuring the highest standards of clinical excellence and patient safety. What You'll Do: - You will lead the design, planning, and execution of clinical development programs for gene therapies targeting rare disorders. - You will collaborate with internal teams and external partners to ensure alignment on clinical objectives and regulatory strategies. - You will oversee clinical trial operations, including site selection, patient recruitment, and data integrity. - You will manage clinical development budgets and timelines to meet organizational goals. - You will provide leadership and mentorship to clinical development teams, fostering a culture of innovation and accountability. - You will engage with regulatory authorities to facilitate approvals and ensure compliance with global regulations. - You will analyze clinical data to inform decision-making and support product lifecycle management. - You will represent Orchard Therapeutics at scientific conferences and industry forums to enhance the company’s visibility. What You Bring: - Minimum of 10 years of clinical development experience in the biopharmaceutical or gene therapy industry. - Proven track record of leading successful clinical programs, preferably in rare diseases or gene therapy. - Strong knowledge of regulatory requirements and clinical trial design. - Excellent leadership, communication, and interpersonal skills. - Advanced degree in medicine, life sciences, or related field (MD, PhD, or equivalent). - Experience working in a global, cross-functional environment. Bonus Points If You Have: - Experience with gene-modified hematopoietic stem cell therapies. - Prior leadership role in a gene therapy or rare disease company. - Familiarity with both US and EU regulatory landscapes. - Published scientific research or presentations at major conferences. What We Offer: - We offer a dynamic and collaborative work environment committed to innovation and patient impact. - We offer competitive compensation and comprehensive benefits including health, dental, and vision insurance. - We offer opportunities for professional growth and development within a global leader in gene therapy. - 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 patients’ lives. 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 strategies and execution for gene therapy programs, managing global clinical trials and collaborating with cross-functional teams to ensure regulatory compliance and successful program advancement. | Minimum 10 years clinical development experience in biotech/pharma, strong gene therapy or rare disease background, leadership in managing clinical teams and global trials, advanced degree in life sciences or medicine, excellent communication and strategic 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 headquarters in Boston, MA, and London, UK, we focus on innovative gene therapies based on gene-modified hematopoietic stem cells, striving to bring groundbreaking treatments to those in need worldwide. Role Overview: As Vice President of Clinical Development, you will lead the strategic planning and execution of clinical programs to advance Orchard Therapeutics' pipeline. Reporting directly to the Chief Medical Officer, you will play a critical role in driving clinical development efforts that support regulatory approvals and successful commercialization. What You'll Do: - You will develop and implement clinical development strategies aligned with company goals and regulatory requirements. - You will oversee the design, execution, and management of clinical trials across multiple global sites. - You will collaborate with cross-functional teams including regulatory affairs, medical affairs, and commercial to ensure seamless program progression. - You will lead and mentor clinical development teams, fostering a culture of innovation and excellence. - You will manage relationships with external partners, investigators, and key opinion leaders. - You will ensure compliance with all regulatory guidelines and maintain high standards of clinical data integrity. - You will contribute to the preparation of clinical sections for regulatory submissions and presentations. - You will monitor clinical trial progress and provide regular updates to senior leadership. What You Bring: - You have at least 10 years of experience in clinical development within the biotechnology or pharmaceutical industry. - You possess a strong background in gene therapy or rare diseases clinical programs. - You have proven leadership experience managing clinical teams and complex global trials. - You hold an advanced degree in life sciences, medicine, or a related field. - You demonstrate excellent communication, strategic thinking, and problem-solving skills. - You are knowledgeable about regulatory requirements and clinical trial design. Bonus Points If You Have: - Experience working in gene-modified hematopoietic stem cell therapies. - Prior experience in a senior leadership role within a gene therapy company. - Familiarity with global regulatory agencies including FDA, EMA, and PMDA. - Experience managing partnerships with academic institutions and industry collaborators. What We Offer: - We offer a dynamic and collaborative work environment committed to 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 pioneering company transforming 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 lives through gene therapy.
Lead and oversee clinical development strategy and execution for gene therapy programs, managing cross-functional teams and regulatory interactions. | At least 10 years of clinical development experience in biotech/pharma with a focus on gene therapy or rare diseases, advanced degree, and strong leadership 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 headquarters in Boston, MA, and London, UK, we focus on innovative gene therapies based on gene-modified hematopoietic stem cells, striving to bring groundbreaking treatments to those in need worldwide. Role Overview: As 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 multiple gene therapy programs. - You will manage cross-functional teams including clinical operations, regulatory affairs, and medical affairs to ensure alignment and successful program execution. - You will oversee clinical trial design, site selection, and patient recruitment strategies to optimize study outcomes. - You will collaborate with regulatory agencies to facilitate approvals and ensure compliance with global regulatory requirements. - You will provide strategic input on clinical data analysis and interpretation to support product development and commercialization. - You will mentor and develop clinical development staff, fostering a culture of innovation and excellence. - You will represent Orchard Therapeutics at scientific conferences and industry meetings to communicate clinical progress and build partnerships. What You Bring: - You have at least 10 years of experience in clinical development within the biotechnology or pharmaceutical industry, with a focus on gene therapy or rare diseases. - You possess a strong understanding of clinical trial design, regulatory requirements, and drug development processes. - You have proven leadership experience managing cross-functional teams and complex clinical programs. - You hold an advanced degree in medicine, life sciences, or a related field (MD, PhD, or equivalent). - You demonstrate excellent communication, strategic thinking, and problem-solving skills. Bonus Points If You Have: - Experience working in global clinical development environments, particularly in the US and EU. - A track record of successful regulatory submissions and approvals for gene therapy products. - Familiarity with hematopoietic stem cell gene modification technologies. - Established relationships with key opinion leaders and regulatory agencies in the rare disease space. What We Offer: - We offer a dynamic and collaborative work environment committed to innovation and patient impact. - We offer competitive compensation and comprehensive benefits including health, dental, and vision insurance. - We offer opportunities for professional growth and development within a leading gene therapy company. - We offer flexible work arrangements to support work-life balance. - We offer the chance to be part of a mission-driven team transforming 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 lives through gene therapy.
Lead and oversee clinical development strategy and execution for gene therapy programs, ensuring regulatory compliance and cross-functional collaboration. | At least 10 years of clinical development experience in biotech/pharma, advanced degree, strong leadership and project management skills, and expertise in gene therapy clinical development. | 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 Vice President of Clinical Development, you will lead and oversee the clinical development strategy and execution for Orchard Therapeutics' gene therapy programs. Reporting directly to the Chief Medical Officer, you will play a critical role in advancing clinical trials, ensuring regulatory compliance, and collaborating cross-functionally to bring innovative therapies to patients. What You'll Do: - You will develop and implement clinical development plans aligned with company goals and regulatory requirements. - You will lead clinical trial design, execution, and data analysis to ensure robust and compliant study outcomes. - You will manage relationships with key stakeholders including regulatory agencies, clinical investigators, and partners. - You will oversee clinical operations teams to ensure timely and efficient trial conduct. - You will collaborate with cross-functional teams including research, regulatory affairs, and commercial to support product development. - You will monitor clinical development budgets and resource allocation to optimize program efficiency. - You will provide leadership and mentorship to clinical development staff, fostering a high-performance culture. - You will stay abreast of industry trends and regulatory changes to inform strategic decisions. 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 regulatory pathways. - You have a proven track record of leading successful clinical trials from early to late phases. - 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 navigating complex regulatory environments. Bonus Points If You Have: - Experience in rare disease or gene therapy clinical development. - Familiarity with hematopoietic stem cell gene-modified therapies. - Prior experience in a senior leadership role within a biotech company. - Knowledge of global regulatory requirements and submission processes. What We Offer: - We offer a dynamic and collaborative work environment committed to innovation and patient impact. - We offer competitive compensation 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 pioneering company transforming 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 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.
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