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Kriya Therapeutics, Inc. · 15 hours ago

Director, Clinical Development

North Carolina, United States

Full-time

Hybrid

Director/Executive

10+ years exp

Kriya Therapeutics, Inc. is a biopharmaceutical company focused on developing gene therapies for diseases with high unmet needs. The Director of Clinical Development will lead and oversee Phase 1-3 clinical studies, ensuring the quality and integrity of the research through collaboration with various stakeholders.

BiotechnologyHealth CareLife ScienceNeuroscience

Growth Opportunities

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

Qualification

Clinical trial designGene therapy experienceDrug development experienceMetabolic experienceData review toolsClinical study documentsCommunicationLeadership skillsInterpersonal skillsAttention to detail

Required

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

Experience leading all stages of clinical trials and possess knowledge of first-in-human clinical trial design

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

Preferred

Metabolic experience highly preferred

Gene therapy experience in a biotech company preferred

Benefits

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!

Company

Kriya Therapeutics, Inc.

Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease.

Founded in 2019

Palo Alto, California, USA

51-200 employees