Clinical Development Director
4 weeks ago
One Kendall Square, Building 600 Cambridge, MA 02139
Korro Bio, a publicly traded biopharmaceutical company, pioneers the frontier of genetic medicine by harnessing the power of RNA editing. Our mission is clear: to discover, develop, and commercialize innovative therapies addressing both rare and prevalent diseases. At Korro, we're not just following trends; we're setting them.
Our groundbreaking approach focuses on editing RNA, allowing for precise and transient single base edits. By targeting RNA, we expand the possibilities of genetic medicine, offering increased specificity and improved long-term tolerability.
Currently, Korro boasts a robust portfolio of differentiated programs, each strategically designed to leverage the body's natural RNA editing processes. Powered by our proprietary platform, Korro is poised to deliver on our commitment to patients. With established regulatory pathways and cutting-edge delivery modalities, we're primed to bring these life-changing medicines to those who need it most. Join us as we redefine what's possible in genetic medicine and make a lasting impact on human health.
Key Responsibilities:
·Clinical Development Strategy: Develop and implement clinical development plans for RNA-based therapeutics, including study design, protocol development, and overall clinical trial strategy.
·Study Execution: Oversee the planning, initiation, conduct, and closeout of clinical trials, ensuring adherence to protocol, regulatory requirements, and timelines.
·Data Management and Analysis: Collaborate with cross-functional teams to ensure high-quality clinical trial data collection, management, and analysis in accordance with GCP standards.
·Safety Monitoring: Manage safety monitoring activities, including adverse event reporting, safety data review, and risk management strategies to ensure patient safety throughout clinical development.
·Regulatory Compliance: Ensure compliance with regulatory requirements, guidelines, and standards governing the conduct of clinical trials, including FDA, EMA, and ICH guidelines.
·Cross-Functional Collaboration: Collaborate closely with other functional areas, including Regulatory Affairs, Clinical Operations, Medical Affairs, and Translational Sciences, to align clinical development activities with overall development plans and goals.
·KOL Engagement: Build and maintain relationships with key opinion leaders and external experts to gather insights, drive scientific exchange, and inform clinical development strategies.
·Vendor Management: Manage relationships with CROs, central laboratories, and other external vendors to ensure the highest quality of deliverables within budget and timelines.
·Budget Management: Develop and manage clinical trial budgets, including forecasting and tracking of expenses, to ensure efficient resource allocation and cost-effective trial execution.
·Team Development: Build and mentor a high-performing clinical development team, fostering a culture of excellence, collaboration, and continuous learning.
Qualifications:
·Advanced degree in life sciences or related field (MD, PhD, or equivalent).
·Medical specialty training with Board Certification.
·Minimum of 8 years of experience in clinical development within the biotech/pharmaceutical industry, with a focus on drug development and clinical trial management.
·Experience in rare disease indications and RNA therapeutics is highly desirable.
·Strong understanding of clinical trial design, conduct, and execution, with knowledge of GCP and regulatory requirements.
·Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
·Meticulous attention to detail, with a focus on quality, accuracy, and compliance.
·Proven ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
·Budget-conscious mindset with a track record of delivering projects on time and within budget.
Why Join Korro Bio:
·Opportunity to be at the forefront of clinical innovation in the development of RNA-based therapeutics for rare diseases.
·Collaborative and entrepreneurial work environment where innovation and creativity are encouraged and valued.
·Competitive compensation package including salary, bonus, equity, and benefits.
·If you are passionate about advancing the development of cutting-edge RNA therapeutics and thrive in a dynamic and fast-paced environment, we encourage you to apply for this exciting opportunity to join the Korro Bio team.
#J-18808-Ljbffr
-
Associate Director, Clinical Operations
1 month ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
Associate Director, Clinical Operations
2 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
Medical Director, Clinical Development
1 month ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
-
Cambridge, United States Clinical Dynamix, Inc. Full timeGlobal Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office)The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This...
-
Cambridge, United States Clinical Dynamix, Inc. Full timeGlobal Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office)The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This...
-
Medical Director, Clinical Development
1 month ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
-
Medical Director
3 weeks ago
Cambridge, United States FogPharma Full timeWhy join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by...
-
Medical Director
6 days ago
Cambridge, United States FogPharma Full timeWhy join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by...
-
Clinical Development Director
6 days ago
Cambridge, United States Korro Bio, Inc. Full timeKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's natural RNA editing process to effect a precise yet transient single base edit....
-
Director, Clinical Development
1 week ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a physician to develop, execute and lead clinical trials supporting one or more development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, Family Practice, Geriatrics, Pediatrics, or Obstetrics/Gynecology is desirable. At least two years of clinical research and/or industry...
-
Sr Project Manager
4 days ago
Cambridge, United States Maxis Clinical Sciences Full timeJob DescriptionJob Description Responsibilities• Drive Design thinking workshops with focus on discovering key business challenges for business objectives• Execute and deliver strategic enabling projects by building engagements with internal SMEs across IT (Cloud/Data/Infrastructure/IT Compliance) and business functions etc• Author, develop and...
-
Clinical Director
3 weeks ago
Cambridge, United States Empowered Staffing Full timeJob DescriptionJob DescriptionEmpowered Staffing is partnered with a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient drug and alcohol...
-
Clinical Director
3 weeks ago
Cambridge, United States Empowered Staffing Full timeJob DescriptionJob DescriptionEmpowered Staffing is partnered with a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient drug and alcohol...
-
Cambridge, United States Biogen Idec Full timeCompany DescriptionJob Description About the role: The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic expansion,...
-
Cambridge, United States Biogen Idec Full timeCompany DescriptionJob Description About the role: The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic expansion,...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic...
-
Associate Director
4 weeks ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionAssociate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C...
-
Director - Business Development
2 weeks ago
Cambridge, Massachusetts, United States Novo Nordisk Full timeAbout the Department The Novo Nordisk Cambridge location is the headquarters for Global Business Development across all of our therapeutic and technology areas.We contribute to innovation in one of the world's largest life sciences ecosystems by participating in events and discussions with renowned and upcoming scientists-looking for the next scientific...
-
Director - Business Development
3 weeks ago
Cambridge, Massachusetts, United States Novo Nordisk Full timeAbout the Department The Novo Nordisk Cambridge location is the headquarters for Global Business Development across all of our therapeutic and technology areas.We contribute to innovation in one of the world's largest life sciences ecosystems by participating in events and discussions with renowned and upcoming scientists-looking for the next scientific...
