Clinical Outsourcing Manager
The Clinical Outsourcing Manager is an instrumental role in the development and management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs. Responsibilities include clinical CRO/vendor identification, RFI/RFP development and execution, vendor selection, contract negotiations, budget management/forecasting, and service provider performance metrics development and tracking.
**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.
- Develop and document best practices for identifying, benchmarking and contracting clinical vendors
- Generate Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers for clinical trials; manage bid defense and proposal review meetings
- Ensure successful study start-up by identifying key vendors, developing contracting timelines, and engaging business partners; facilitate contract negotiation as appropriate
- Assess portfolio resource demand and shortfall/mitigations for current and potential future portfolio with key vendors, including development of a database for identifying and maintaining current and potential service providers
- Negotiate and execute vendor contracts and manage contract lifecycle in collaboration with legal
- Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers
- Negotiate change orders and ensure service providers adhere to contract terms
- Review invoices against vendor contracts to ensure accuracy and service completion in partnership with Clinical Trial Manager(s)
- Ensure strategic vendor relationships are running efficiently and productively
- Actively manage clinical contractual obligations and support oversight of clinical trial execution with external partners
- Coordinate Joint Operations Committees and Executive Steering Committees with CROs on behalf of Precision BioSciences (including agendas, minutes, follow-up on action items)
- Develop KPIs and vendor performance scorecards to ensure the highest quality of outsourced delivery of Clinical Programs, on time and within budget
- Ensure appropriate governance documentation of partnerships is developed and maintained
- Address areas of concern and provide recommendations to mitigate against poor performance
- Act as vendor management lead for relationships with CROs
- Support integration of Precision BioSciences and CRO teams and process to facilitate success of new collaborations
- Assist with creating clinical trial budgeting models and scenario planning for future trials
- Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- Bachelor’s degree in finance, life sciences or related discipline with 7+ years of related experience in clinical operations or finance or Master’s degree in finance, life sciences or related discipline with 5+ years of related experience in clinical operations or finance or equivalent combination of education and experience
- Experience in project management of internal and external clinical study programs
- Experience with external vendor collaborations including CROs
- Experience in alliance management
- Experience in negotiating complex contracts including performance-based terms
- Relevant experience in Clinical Development
- Strong negotiation skills and a proven ability to manage others through influence
- Good understanding of contract management
- Broad knowledge of pharmaceutical drug development across the development lifecycle
- A demonstrated background in developing, implementing, and managing outsourcing strategies
- Ability to effectively partner, build trust and work with, and influence executive level stakeholders
- Demonstrated abilities in strategic planning and leadership skills & excellent business acumen
- Demonstrated ability to function independently with a proactive, self-starter attitude
- Highly effective and proactive verbal & written communication skills to ensure optimal level of engagement with all key stakeholders
- Highly effective team player with strong interpersonal skills (globally, internally and externally)
- Strong customer focus
- MBA or JD
- A strong foundation in clinical operations, clinical outsourcing, or CRO experience
- Minimal travel will be expected for this position.
- 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.