Director, Clinical Operations
The Director, Clinical Operations (Clin Ops) is responsible for overseeing the conduct of clinical trial(s) from vendor selection through Clinical Study Report (CSR) completion. The position is accountable for successful delivery of clinical trial(s) as agreed with regard to planning, execution, budgets and timelines. The position also ensures that activities at the project level are met by participating in product teams and keeping colleagues informed about clinical trial needs and timelines. Also as a Director, the position will interface with leaders across departments within Precision, including members of the senior leadership, other key functional leads and externally with investigators, KOLs, advisory boards and CROs. Company wide responsibilities may also include membership and possible leadership in key committees.
Responsibilities include oversight of the Clinical Ops team, which includes designating roles and responsibilities of team members capable of overseeing vendors and clinical research organizations and direct interaction with site, as well as providing them mentorship. The Director, Clinical Operations will also provide strategic input into trial design and study conduct efficiency. The Director will also generate a Clinical Ops team matrix structure outlining roles and responsibilities for each operational project and will have input into company level budget planning and portfolio prioritization.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
Directs Clinical Operations function including:
- Oversight of Project Administration – ensures productive liaison between the Company and vendor(s) to ensure study launch, conduct, and closeout according to company and regulatory requirements. Includes oversight of project organization, implementation, financial/contracts and management activities between all Company operations and vendors.
- Project Specific (external)– ensures CRO/vendors are engaged as needed to deliver on the timelines, e.g. provides feedback and approval as needed for site selection from site feasibility assessments. Reviews protocol, Case Report Forms and other study documents for consistency and to ensure study goals are being met. Reviews and approves project plans for the study in accordance with Standard Operating Procedures (SOPs). Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
- Project specific (internal) – Participates on product development teams to ensure timelines are understood and study needs are met. Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and management. Alerts management to potential issues and ensures necessary corrective action is taken. Ensure data needs are met with regard to safety reporting, safety review committees, and investigator meetings.
- Team management (internal) – Responsible for creation of team matrix structure per project, projection of FTE needs to match required effort, creation and management of internal SOPs for Clin Ops in collaboration with Quality, interaction with CMC group to ensure adequate CTM, and interaction with translational team for assessment of sample collection, processing, and analysis.
- Portfolio strategy – assessment of resource requirements for Clin Ops for each potential Development candidate, evaluation of internal hiring vs external vendors for optimal balance of efficiency and flexibility.
- Communication – Is a main contact for Precision for both vendors and clinical sites. Attends investigator meetings, SIVs, DSMBs as needed to represent Precision and to maintain productive relationships between Precision/CROs and clinical sites.
- Vendor Management - Develops strong relationships with vendors to support project needs. Responsible for selection of CROs and vendors in accord with Procurement needs including Request for Proposals and evaluating potential CROs (and/or other vendors), including proposal defense meetings.
- Knowledge/Training – ensures clinical operations team has mastery of current therapeutic environment and drug development trends. Facilitates internal / external training requirements in accordance with protocol and/or project initiation, set-up, requirements, including therapeutic, protocol specific, and process training
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- BA/BS in the life sciences, nursing degree or related field and 12+ years of clinical research experience in a biotechnology company, contract research organization (CRO), or pharmaceutical company or equivalent combination of education and experience. Title will be considered commensurate with experience.
- Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, biotechnology / pharmaceutical company, or CRO; 2+ years must have been spent actively managing the full scope of clinical research projects (i.e. accountability across all functional areas and including budget ownership)
- Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures
- Demonstrated proficiency with ICH/GCP guidelines
- Keen insight, independent judgment, and tactful discretion. Strong ability to manage time and work independently. Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach. Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), web-based systems, email, and voicemail skills. Experience with timeline management systems / programs (MS Project, Smartsheet, Mavenlink, etc.)
- Flexibility and the ability to mentor new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment. Ability to assist in and / or champion establishing and maintaining standards, system integrity, and ensuring quality assurance measurements
- Demonstration of budget and forecasting capabilities; capability to evaluate risk/reward in strategic evaluation of portfolio candidates
- 3+ years of management experience overseeing Clinical Trial Managers, Clinical Research Assistants, and Clinical Research Associates; demonstrated capability to assign resources per prioritization
- Therapeutic experience in clinical stage Oncology trials (ph I – III)
- Experience in early phase trials (ph I – II)
- Experience as a traveling Clinical Research Associate / Clinical Site Monitor
- Minimal travel may be required (up to 25%).
- This is an office-based position located at the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.