Associate Director/Director, Development Program Leader

Location
Durham, NC
Posted
Jul 08, 2019
Ref
1000768
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
Precision Biosciences is seeking an Associate Director or Director of Program Development to drive its pipeline of gene and cell therapy preclinical and early clinical development programs. This individual will be responsible for leading teams dedicated to the translational development activities necessary to advance gene and cell therapy programs from research proof of concept to the end of Phase 1 clinical trials.

This position will report to the Development Leader. The successful candidate will be a hands-on, participative manager who will make significant contributions to therapeutic strategy and execution within a diverse R&D organization.

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.
  • Lead cell /gene therapy preclinical and early clinical development programs irrespective of indication or therapeutic area
  • Design and implement program strategies for the efficient advancement of research programs to IND enabling and, subsequently, Phase 1 studies
  • Ensure appropriate program planning and alignment, including identification of decision points and milestones and incorporating the required pre-clinical and validation studies, while managing risk to meet short and long-term objectives
  • Collaborate with cross-functional teams to develop a working product profile for each advancing program consistent with the intended therapeutic use and competitive environment
  • Communicate program rationale, strategy and updates to internal stakeholders
  • Demonstrate a strong appreciation for research but a focus on translational science and product development
  • Monitor and respond to an evolving external competitive environment
  • Build a project team that draws on existing skills and resources within the company as well as external resources as required
  • Adapt quickly to technical and/or industry changes in a rapidly advancing field
  • Lead while maintaining a company culture that emphasizes selflessness and team success
  • Develop a budget and make decisions on administrative and operational matters for the team

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
  • MS or PhD in a biological or chemical science or equivalent experience
  • Strong translational development experience, preferably in cell or gene therapy
  • 6+ years of experience within the pharmaceutical industry required, experience in more than one functional area within the industry is a plus
  • At least 2+ years of project team and/or leadership experience
  • Demonstrated track record in the delivery of drug candidates from preclinical development through IND
  • Broad knowledge of drug development processes and industry best practices, including clinical and non-clinical study design and execution
  • Thorough familiarity of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
  • Experience with CAR T-cell therapies or in vivo gene editing preferred
  • The ability to work in a fast-paced, small company environment that demands rapid progress and creative problem solving
  • The ability to effectively communicate data and results both internally and externally and to manage collaborations with academia and industry partners
  • The ability to manage multiple therapeutic programs in parallel and prioritize according to the needs of the company while delivering on key milestones

Work Environment

The work environment characteristics described here are representative of those an employee could potentially encounter while performing the essential functions of this job.
  • Utilize a computer and MS office to facilitate program management
  • While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; biohazardous, toxic, or caustic chemicals and risk of electrical shock
  • The noise level in the work environment is usually moderate

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • The employee must occasionally lift and/or move up to 25 pounds
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel, and talk or hear
  • The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell

Travel Requirements
  • The position may require travel (5-10%)

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.