Director/Associate Director, Research and Development, Cell Therapy

Location
San Diego County, California
Posted
Jun 29, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time

Summary:

Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases. Shoreline Biosciences is seeking experienced, highly motivated individuals responsible for leading cross-functional projects across the company's continuum of research and development with the goal of advancing Shoreline’s cutting-edge iPSC-derived NK cell and Macrophage cancer immunotherapies. He / She will work closely with our Collaboration Partners and internal colleagues to efficiently progress early-stage Cell Therapy programs through IND filing. He / She will also oversee tech transfer to the GMP facility and support the design of clinical trials. This will be a full-time position located at our corporate headquarters in San Diego, CA. The level of the position and compensation package will be competitive and tailored to the specific level of the candidate. This position will report directly to the Senior Director of Research & Development, Cell Therapy.

Responsibilities:

  • Lead Cell Therapy programs from early-stage to IND-enabling studies.
  • Collaborate efficiently with cross-functional teams and collaborators to create and implement gene editing strategies for Cell Therapy programs
  • Drive the evaluation and development of cutting-edge gene-editing technologies and platforms.
  • Manage the work of multiple reports and leverages CROs and academic collaborators effectively to drive programs forward.
  • Oversee tech transfer of process and analytical assays to GMP facilities or collaborators.
  • Proactively find and supervise solutions to bottlenecks, deviations, risks, and changes that could lead to planning conflicts, project delays, or cost changes.
  • Provide support for drafting study reports, patents, SOPs, and peer-reviewed scientific publications.
  • Provide support for drafting and reviewing relevant regulatory submissions.
  • Provide mentorship and support to direct reports and other team members as subject matter experts.
  • Present and report project progresses to internal stakeholders and external collaborators.

Qualifications:

  • Ph.D. in Biological Sciences, Immunology, Molecular Biology, Biochemistry, or related field with a minimum of 8 years industry experience.
  • Proven leadership and management experience in the biotech and/or pharmaceutical industry.
  • Prior experience with the cell therapy process and analytical development is desired.
  • Prior experience with IND, NDA, or BLA is strongly preferred.
  • Strong knowledge of Immunology and/or Cancer Biology.
  • A strong academic career with high-caliber publications in peer-reviewed journals is preferred.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Excellent interpersonal, verbal, and written communication skills.
  • Strong people management skills and ability to build, influence, and lead a team.
  • Self-motivating and creative, able to work within a team and collaborate proficiently with colleagues to achieve program goals.

Required Competencies:

  • Competency in partnership development and project management
  • Well-organized and able to handle multiple tasks and changing priorities.
  • Developing partnerships and cultivating relationships, designing partnership arrangements, facilitating partner negotiations, and managing partnership interactions
  • Knowledge of immunobiology is an asset.
  • Excellent in building relationships and representation
  • A solid understanding of timelines, human resources, and budgets necessary for clinical trials is preferred. Recent experience with a smaller entrepreneurial environment is a plus Strong autonomy, with a team working focus.
  • Stress resistant and must have strong interpersonal skills capable of working with a diverse group of people.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
  • The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.
  • Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • This position requires the ability to lift and/or move up to 25 pounds occasionally.

Work Environment:

  • Will require working with cells and cell lines of human and/or animal origin.
  • Will require working with hazardous materials.
  • Work in and around common laboratory equipment.
  • The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment.
  • 100% on-site work at corporate headquarters in San Diego, CA.
  • Evening and weekend work as necessary.

Disclaimer:

  • The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
  • For immediate consideration, please apply to careers@shorelinebio.com
  • Visit our website to find out more about Shoreline Biosciences: https://www.shorelinebio.com/.
  • NO PHONE CALLS, PLEASE.  PRINCIPALS ONLY
  • Shoreline Biosciences, Inc. is proud to be an EEO Employer.