Senior Program Manager/Program Manager

Location
Durham, NC, United States
Posted
Jan 10, 2021
Ref
1463949
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The CMC Program Manager will be a key member of our CMC team and will work with the CMC function to develop and implement operational excellence to support Precision Biosciences Cell and Gene Therapy programs. This is a unique opportunity to shape the CMC program at a rapidly growing biotechnology company focused on the development of highly novel genome-edited therapeutics. Most importantly, the Incumbent will play a key role in the conceptualization of CMC strategy and tactical execution for Precision Biosciences' first in vivo gene therapy programs which aim to address unmet medical needs for intractable genetic diseases.

This position is a matrix management role that will collaborate with multiple functions in CMC and across the overall organization (including Clinical, Regulatory, Quality, Clinical, Operations, Clinical Trial Supply, IT, Market Access and Finance). The incumbent will primarily assist program leadership teams and CMC leads in the strategy definition and execution of several CMC programs. They will contribute to the elaboration, implementation and maintenance of appropriate program management tools, plans and processes to support clear communication, decision making, risk-mitigation, prioritization and resource planning. They will be responsible for mapping out, implementing and tracking detailed CMC development plans to ensure that program goals and milestones are achieved in keeping with timelines, financial, quality and regulatory requirements.

This role is highly complex and applies project management as well as knowledge of CMC development for complex biologics. Experience can come from formal program or project management roles as well as through hands-on experience in scientific, technical, and/or operational roles in biologics and/or pharmaceutical development. The ideal candidate will have experience working in CMC with Regulatory, Quality Assurance and Clinical operations to support early and late stage development programs (BLA/MAA submissions). They must have a high level of independence to carry out their responsibilities with minimal supervision. This is a highly visible role in the organization, and they will interact extensively with partners in CMC and across the whole organization. For this reason, a successful candidate must possess strong interpersonal and communication skills.

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.
  • Assist CMC and programs teams in the development of CMC strategic roadmap to support clinical phases, submissions (IND/IMPD and BLA/MAA) and launch preparation
  • Contribute to the elaboration of the CMC stage gates, milestones for early and late stage development programs
  • Support the implementation of the CMC development plans by developing, owning and maintaining detailed CMC timelines and budgets for multiple CMC programs
  • Monitor changes in execution schedule, budget and project requirements to anticipate and limit delays and identify temporal choke points and resource tradeoffs between programs for mitigations
  • Assist CMC teams in the identification, evaluation and escalation of project risks (business, regulatory, quality and technical) throughout projects lifecycles and guide them to devise appropriate mitigation strategies
  • Develop tools to provide consistent CMC reporting and status update to Program teams, CMC and executive teams to ensure alignment and clarity across the organization in support of effective decision-making
  • Develop and maintain communications plans and facilitate meeting occurrences, plan agendas, maintain project/topic trackers
  • Serve as a key liaison between CMC leads, functions and programs teams
  • Contribute to the operationalization of the CMC function by developing and implementing best governance tools, process and practices
  • Provide guidance on best practices to support harmonization, efficiencies, and continuous improvements across programs, platforms and organizations


Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:
  • Bachelor's degree in engineering, chemical or biochemical sciences or relevant discipline
  • 5+ years of related CMC experience in the biotech/pharmaceutical industry with exposure to all stages of biologics development (IND/IMPD, BLA/MAA, and Commercialization)
  • Proven record of successful technical leadership of CMC teams and programs
  • Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower teams in a cross functional, complex and changing environment
  • Clear understanding of process and functional interdependencies required to deliver a biological product to the clinic
  • Strong problem solving and risk-based decision-making skills and a strong ability to influence or manage without direct authority
  • Excellent interpersonal, communication (verbal and written) and negotiation skills; demonstrated critical thinking and innovation ability
  • Proficiency with Microsoft Office software suite and project management software
  • Outstanding project management and coordination capabilities; must be able to support multiple project teams simultaneously
  • Personal alignment with Precisions values, mission and vision

Preferred:
  • Advanced degree in Engineering or Life Sciences, MBA and/or PMP certification
  • Strong understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOPs
  • Assertive, take-charge, proven manager, team player with a strong results orientation, positive can do attitude, and a sense of urgency to get things done
  • High emotional intelligence, sound temperament and professional attitude; good common sense and judgment

Travel Requirements
  • This position may require limited travel (10-15%).

Location
  • This is a primarily office-based position associated with 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 is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

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.