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Job: Head of Clinical Operations, Path BioAnalytics, Inc., Chapel Hill, NC
Head of Clinical Operations
Chapel Hill, NC 27514 United States
173 1/2 East Franklin St.
Path BioAnalytics, Inc. (PBA) is an emerging biotech company based in Chapel Hill, NC. We are developing assays and databases for precision medicine by combining innovative epithelial cell culture technology with proprietary AI-based analytics.
PBA is seeking a Head of Clinical Operations to lead a breakthrough multi-stakeholder clinical program in the respiratory space. Responsible for program oversight and evaluation and integration of cutting-edge technologies to maximize program results and surpass goals.
Additional responsibilities include:
- Manage, and engage multiple program stakeholders and establish support base.
- Evaluate technical, protocol-specific, and operational aspects of clinical program from early stage pre-clinical through clinical trials.
- Develops and implements pathways that enable accelerated approval &/or compression of regulatory timelines, particularly for therapies needing orphan drug designation.
- Develops strategies for improvement of programs, identify technological hurdles and evaluate solutions to these hurdles.
- Ensures all programs are clearly defined implemented effectively, and supported by appropriate resources, within designated cost budgets.
- Provides regular updates to team for all clinical research activities, including proactive identification of work streams and dependencies, key risk indicators, achievements, resources, issues, and milestones.
- Ensures compliance with medical, legal and regulatory code requirements. Ensures all activities of clinical programs comply with the company standards, SOPs, and the PhRMA Code on Interactions with Healthcare Professionals, OIG, ICH/GCP guidelines, HIPPA, anti-kickback and fraud and abuse legislation and contribute to the monitoring of compliance with such codes.
- Oversees investigator recruitment/selection and the conduct of trials at investigative sites.
- Manages and trains clinical research associates if needed.
- Participates on site visits as required (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim monitoring visits, and close-out visits), evaluates CROs/contract monitors through co-monitoring visits and/or site audits as required; Reviews monitoring trip reports.
- Supports site recruitment and patient recruitment.
- Maintains primary responsibility for the content and execution of all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans.
- Manages investigational project accountability and reconciliation processes.
- Tracks study progress ensuring timely data collection, monitoring and collaboration with data management.
- Helps to develop and review IRB documentation and all other clinical trial related documentation as required. Management of IRB.
- Oversees collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files.
- Responsible for development of annual budgets and forecasting programs. Ensures all expenditures are managed in accordance with agreed budgets and forecasts by closely monitoring each clinical program and proactively addressing issues.
- Maintains strong business relationships with key personnel through effective collaboration and communication
- Effectively manages the Clinical Operations team to ensure robust processes and procedures are in place for operational management of contracts, staff selection, development, and performance management of staff.
Creative problem solving and dedication to operation efficiency are essential. This position requires the ability to act independently and to take initiative with no supervision, function cooperatively with a diverse, high-performing team, and operate under stress and ambiguity in an entrepreneurial environment.
BS/BA degree with background in life sciences. Advanced degree is preferred.
- Must have substantial experience advancing therapeutic programs - 12+ years of applicable experience (biotech/pharma/ Univeristy /CRO) with at least 8 years of clinical operations management experience. At least 8 years of industry experience preferred.
- Experience with respiratory programs preferred, experience with CF and COPD programs strongly preferred. Prior experience with complex trial design is ideal.
- Extensive experience in managing clinical trials from start to finish.
- Strong understanding of relevant regulatory requirements.
- The successful candidate will possess strong interpersonal, teamwork, and collaboration skills. In addition, possesses strong workload planning skills, organization, attention to detail, and follow through.
- Strong operational and management skills. Strong sense of ownership; results- and accountability-driven.
- Must have excellent written and verbal communication skills. Ability to prioritize and multi-task concurrent project demands.
- Strong computer skills
- Ability to translate business acumen and management objectives into actionable and successful goals and plans.
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