Director, Clinical Development

Department: Clinical

Employment Type: Full Time

Location: Research Triangle Park, NC

Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview

The Director of Clinical Development is a motivated and experienced Clinical Scientist experienced in Phase 1-3 clinical studies. This individual will use their in-depth knowledge and experience to provide scientific input during protocol development, study design, oversight of study conduct, and interpretation of study results through the final study report. They will ensure the quality and integrity of the research through your successful collaborations with other scientists, clinicians, and stakeholders.   

Key Responsibilities

• Lead the preparation of clinical study related documents including protocols, charters, meeting presentations, publications, and clinical sections of regulatory documents.
• Support the design and execution of key elements of the Clinical Development Plan (clinical study or studies) within a therapeutic area. 
• Lead or support the clinical sub team and participate in the program team.
• Contributes to preparation of all ancillary study documents including informed consent forms, case report forms, operations manuals, diaries, investigator’s brochures, and operations manuals.
• Assist with the preparation, or oversite of vendor preparation, of data listings, clinical study reports and clinical submission documents.
• Collaborate with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation.
• Collaborate with clinical operations team to review vendor, CRO and site scope of work, study budget, and plans or manuals related to study data, IVRS, central labs, etc.
• Provide scientific expertise for selection of investigators and vendors.
• Develop internal and external training materials and presentations.
• Train colleagues, CRO staff, and study site staff on the clinical protocol
• Responsible for review and analysis of clinical trial data, including summarizing potential safety and efficacy trends, for preparation of interim and final reports of clinical trial data for study documents including CSRs, IBs, and DSURs
• Lead or support the planning and conduct of investigator meetings and advisory boards.
• Responsible for preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the protocol and/or clinical program.
• Oversight of scientific activities outsourced to vendors and clinical research organizations.
• Engage with clinical investigators to ensure quality clinical execution

Experience & Skills and Work Environment

Experience & Skills

• Relevant clinical or biomedical Ph.D. or MSc degree
• 10+ years of demonstrated drug development or medical research experience within the biopharmaceutical industry. 
• An equivalent combination of education and experience is acceptable.
• Metabolic experience highly preferred
• Experience leading all stages of clinical trials and possess knowledge of first-in-human clinical trial design. 
• Gene therapy experience in a biotech company preferred. 
• Experienced supporting clinical trial design, statistics, and data review tools
• Proficiency in development or protocols, case report forms, informed consent documents, and study initiation and monitoring activities
• Proven ability to share scientific data effectively across functions and through presentations.
• Experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends.
• Highly motivated and accountable, self-directed, and able to execute with attention to detail.
• Excellent communication and interpersonal relationship skills including negotiating and relationship building.
• Possess excellent leadership, communication, and organizati