Director/Senior Director, CMC Operations and Strategic Planning

Location
Durham, NC, United States
Posted
Jul 08, 2019
Ref
1076905
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
The Director/Senior Director, CMC Operations and Strategic Planning is a key leader at Precision BioSciences who will create and implement a cohesive CMC operational strategy. This operational framework will drive the evolution of core processes, tools, governance, and communication to ensure the delivery of late stage programs in novel genome-edited cell and gene therapies, and the continued rapid transition of early-stage candidates into the clinic. Managing across portfolio risks, the incumbent will partner closely with Process and Analytical Development, Technical Operations, Manufacturing, and Supply Chain to deliver best-in-class operational execution from IND filing through to commercial launch.

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.

This role is a key position within PBI and is responsible for:
  • Ownership of CMC activities sequencing to enable speed and optimal resource deployment, ensuring appropriate alignment and autonomy for CMC teams
  • Own the functional component of CMC business planning including budgets and resource allocation across the portfolio
  • Creation of a CMC operations analytics framework that allows interrogation of diverse operational scenarios and risk models
  • Partners across functional areas to develop and execute a multi-year roadmap to commercial launch, including Quality, Regulatory, Supply Chain, Clinical, MSAT, HEOR, Technical Operations, Legal, IT, and Finance.
  • Matrix leadership and facilitation of cross-functional team workshops to map current state processes, identify opportunities and define solutions
  • Effective stakeholder management and change management for buy-in and integration of processes, deliverables, technologies and roles/responsibilities into existing CMC teams and infrastructure
  • Project management excellence that includes appropriate scoping, reporting, risk management and issue escalation
  • Performance management, metrics design and measurement, success criteria and outcomes realization

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
  • Advanced degree in the life sciences, engineering, MBA, or equivalent
  • 15+ years of biotechnology or pharmaceutical experience in operational and strategic roles
  • CMC late-stage development and commercial launch experience is desirable
  • Demonstrated abilities in risk analysis such as deploying event chain methodology
  • Demonstrated abilities in operational model creation and decision analysis
  • Excellent coaching skills and a talent for fostering a sense of purpose and belonging in various formal and informal settings
  • Expert skill in facilitating the contribution of diverse members as individuals and as a team
  • Scrum Master, Kanban, Lean Six Sigma, or similar certification is a plus

Travel Requirements

5-10% travel is required for this position

Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com

Precision BioSciences provides 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.