Associate Director, Clinical Scientist

Department: Clinical

Employment Type: Full Time

Location: Research Triangle Park, NC

Description

Role Overview

• 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

• 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.

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.

Life at Kriya

• 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!