The Role
Provide scientific leadership across clinical study lifecycle including protocol and regulatory document development, study design support, data review and analysis, vendor and investigator selection oversight, training, and preparation of abstracts, manuscripts, and clinical study reports to ensure scientific quality and compliance.
Summary Generated by Built In
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.”
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 Associate Director, Clinical Scientist provides scientific input throughout the study lifecycle, from protocol development through final reporting. They ensure the quality and integrity of the research through successful collaborations with other scientists, clinicians, and stakeholders.
Key Responsibilities
Key Responsibilities
- Support the development 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.
- 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.
- Lead or support the development of internal and external training materials and presentations.
- Support training of 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.
- Ensure quality and compliance of scientific activities performed by external partners and clinical research organizations.
Experience & Skills and Work Environment
Experience & Skills
- Relevant clinical or biomedical Ph.D. or MSc degree.
- 5+ years of demonstrated drug development or medical research experience within the biopharmaceutical industry.
- Must have a minimum of 3 years Ophthalmology therapeutic area experience.
- Experience supporting clinical trial design, statistics, and data review tools.
- Experience 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.
- 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 organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.
- Ability to manage projects and interact successfully with external vendors.
- Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style.
- Patient-focused with a deep commitment to understanding patient needs.
Work Environment
- Primarily desk-based, generally in an office or home office setting.
- May involve extended periods of sitting and computer use.
Life at Kriya
Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
- Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
- Health & Wellness: Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
- Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
- And More!
About
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Skills Required
- Relevant clinical or biomedical Ph.D. or MSc degree
- 5+ years of drug development or medical research experience in the biopharmaceutical industry
- Minimum of 3 years ophthalmology therapeutic area experience
- Experience supporting clinical trial design, statistics, and data review tools
- Experience developing protocols, case report forms, informed consent documents, and study initiation/monitoring activities
- Experience reviewing and analyzing clinical trial data and preparing clinical study reports
- Proven ability to communicate scientific data effectively across functions and through presentations
- Ability to manage projects and interact successfully with external vendors and CROs
- Strong leadership, communication, organizational skills, and attention to detail
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The Company
What We Do
Kriya Therapeutics is a biopharmaceutical company dedicated to developing and manufacturing transformative, one-time gene therapies to address chronic diseases affecting millions of people worldwide. With operations in Research Triangle Park, North Carolina, and Silicon Valley, California, Kriya leverages an innovative platform for research, development, and manufacturing to revolutionize medicine and eliminate the burden of disease, aiming to make life-changing therapies accessible to all in need.
