What are the responsibilities and job description for the Director, Clinical Development Science position at Kriya Therapeutics, Inc.?
About Kriya
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
Who You Are
The Director, Clinical Development Science 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 though your successful collaborations with other scientists, clinicians, and stakeholders.
How You Contribute
What You Bring to the Team
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.
What We Offer
Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
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
Who You Are
The Director, Clinical Development Science 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 though your successful collaborations with other scientists, clinicians, and stakeholders.
How You Contribute
- 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 on 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 investigator 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
What You Bring to the Team
- Relevant clinical or biomedical Ph.D. or MSc degree
- 7 years of demonstrated drug development or medical research experience within the biopharmaceutical industry
- Experience leading all stages of clinical trials and possess knowledge of first-in-human clinical trial design preferably with Ophthalmology experience.
- Gene therapy experience in 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 organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.
- Ability to manage multiple 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.
- Primarily desk-based, generally in an office or home office setting.
- May involve extended periods of sitting and computer use.
- Occasional travel requirements
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.
What We Offer
Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
