Job description

Seeking a Senior Director of Clinical Operations to provide strategic leadership for the planning, oversight, and successful completion of all of our clinical trials and clinical trial related milestones within established budgets and timelines. Reporting to the Chief Medical Officer, this position will be highly collaborative, working cross-functionally with many disciplines as necessary for successful clinical trial execution. The ideal candidate is enthusiastic and able to take on new challenges in a fast-paced biotech environment. This individual will manage and oversee CROs, clinical study start-up/execution including site and vendor selection, EC/IRB submissions, patient recruitment, and clinical compliance with SOPs.

Job description and Responsibilities:

• Provides leadership and strategic input for the planning and oversight of all clinical trial deliverables including resourcing and management of vendors to achieve program objectives within established budgets and timelines
• Works collaboratively and communicates effectively with all functional area representatives within senior management and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals
• Directs protocol implementation including site identification and communication, attendance at investigators meetings, site initiation visits, and ensures that clinical trial conduct is in compliance with ICH, GCP, and applicable regulatory requirements
• Oversight of all aspects of clinical trial benchmarks, including identification, measurement, and reporting of key performance indicators (KPIs) such as but not exclusive to CRO contracting, patient screening, first/last patient enrolled, data lock, report finalization, etc.
• Reports study progress/timelines, program updates, achievements, and potential issues/risks to senior management
• Leads the development of clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Supports data analysis and assembly, including clinical study report writing, and contributes to the preparation of abstracts, presentations, and manuscripts and that reported clinical trial data are accurate, complete, and verifiable from source documentation
• Remains up to date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities
• Mentors junior team members to help assure their ongoing career development

Qualifications and Experience:

• BA/BS required, advanced scientific or healthcare-related degree preferred
• 10+ years of professional Clinical Operations experience in the pharmaceutical industry
• A minimum of 5 years of clinical trial management and people management experience
• Infectious diseases experience preferred
• Startup company clinical trial leadership preferred
• Strong background with experience in novel and innovative designs for early Phase I, II, and III clinical trials
• Knowledge of relevant FDA regulations and guidelines; experience with FDA and other health authorities interactions and submission of regulatory documents.
• Must be detail oriented and able to plan and prioritize daily workload with competing priorities
• Excellent interpersonal and influencing skills to work collaboratively with other functions
• Candidates must be authorized to work in the U.S.

PRECISION LIFE SCIENCES

jjbodyshop.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jjbodyshop.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jjbodyshop.com is the ideal place to find your next job.