Director/Senior Director, Clinical Development

About Us

Jnana Therapeutics is a clinical-stage biotechnology company leveraging its next-generation RAPID chemoproteomics platform to discover medicines for highly validated, challenging-to drug targets to treat diseases with high unmet needs. Jnana is focused on developing first- and best-in-class therapies to treat a wide range of diseases, including rare diseases and immune mediated diseases. Jnana's wholly owned lead program, JNT-517, which targets an allosteric site on the phenylalanine transporter SLC6A19, is a potential first-in-class oral approach for the treatment of PKU, a rare genetic metabolic disease. Located in Boston, Jnana brings together scientific leaders in small molecule drug discovery and development, a highly experienced management team, and the backing of leading life science investors Bain Capital Life Sciences, RA Capital Management, Polaris Partners, Versant Ventures, Avalon Ventures, Pfizer Ventures, and AbbVie Ventures. For more information, please visit www.jnanatx.com and follow us on Twitter/X and LinkedIn.

At Jnana, you join a diverse, ambitious, and passionate team dedicated to making substantial advancements for patients across a variety of diseases. The culture at Jnana is one of collaboration and urgency, driven by a shared purpose to deliver innovative therapies for the most challenging targets. Our team's quality and the cutting-edge nature of our science are what make Jnana a great place to work every day – and a place where you belong!

About the Opportunity

Join our growing internal clinical development team on our mission to develop first- and best-in-class therapies that address unmet medical needs through cutting-edge science and collaboration! As our Director/Senior Director, Clinical Development, reporting to the Head of Clinical Development, you will play a pivotal role in advancing our innovative therapies, including our flagship PKU program, JNT-517, through pivotal trials. Utilizing our groundbreaking RAPID platform, you will lead the strategic planning and execution of clinical trials aimed at transforming patient outcomes in rare diseases and immune-mediated disorders.

Responsibilities

• Lead the strategic planning and execution of clinical trials across multiple phases, ensuring robust study design, patient safety, and data integrity.
• Develop and refine clinical trial protocols, incorporating scientific rationale, regulatory requirements, and ethical considerations to drive successful outcomes.
• Manage all aspects of clinical trials, including site selection, investigator meetings, monitoring activities, and data review to meet milestones and deliver high-quality results.
• Collaborate closely with cross-functional teams including Pharmacology, Regulatory Affairs, Product Strategy and Medical Affairs to integrate clinical development plans with overall product strategy and lifecycle management.
• Drive the efficient progression of drug candidates from pre-clinical through clinical development stages to market approval, optimizing timelines and resource allocation.
• Engage with external partners, key opinion leaders, and regulatory authorities to advance clinical development strategies and ensure alignment with global regulatory standards.
• Present clinical development plans, study results, and strategic recommendations to senior leadership, contributing to strategic decision-making processes.
• Monitor industry trends, scientific advancements, and competitive landscape to inform and refine clinical development strategies and maintain Jnana Therapeutics' leadership position.
• Lead data analysis and reporting activities, providing strategic insights to support future development and regulatory interactions.
• Identify and mitigate potential risks and challenges associated with clinical trials, implementing proactive strategies to optimize trial outcomes.
• Assume medical and clinical accountability for assigned clinical studies and programs, including safety monitoring, data interpretation, and risk management.
• In conjunction with regulatory, work to facilitate successful clinical trial submissions and approvals.
• Represent Jnana in discussions with CRO Partners, investigators and site staff.
  
  

Preferred Qualifications

• MD degree (MD, DO, MBBS, MBChB, MBBCh) with a strong track record in biopharmaceutical clinical development.
• Proven experience navigating complex regulatory environments, ideally in rare diseases or immune-mediated disorders.
• Demonstrated leadership in successfully leading clinical trials and driving drug development projects forward.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and with external stakeholders.