Director of In Vivo CGT Services
Pharmaron

San Diego, California

Posted in Pharmaceuticals


This job has expired.

Job Info


Pharmaron is seeking a Director of In Vivo Cell & Gene Therapy (CGT) Services to oversee the science and operations involved in the conduct and execution of preclinical in vivo CGT studies. The position will serve as the subject matter expert in the field of preclinical Cell and Gene Therapy with an emphasis on CGT toxicology and in vivo studies that are integral to CGT IND filings.

Essential Functions

The candidate will provide scientific direction and guidance to the technical staff, assist as a central resource to strengthen US CGT services, with a primary focus on In vivo CGT services at, the San Diego, CA, site. This position also works closely with Site Leadership, Small Molecule, Large Molecule, and CGT bioanalytical teams, Business Development, and Marketing to strengthen the sales of stand-alone and integrated CGT based bioanalytical services. Other important functions include:

  • Provide scientific and technical leadership for in vivo efficacy and toxicology CGT studies across pre-clinical programs.
  • Mentor and guide CGT Study Directors and may serve as Study Director for in vivo CGT studies as needed.
  • Identifies training needs and ensures proper training is developed and provided within assigned teams
  • Contribute to the recruitment of research scientists and support staff. Interview and participate in the selection of qualified departmental personnel. Recommend, personnel actions, including hiring, promotions, and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
  • Monitor the performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews.
  • Oversee and ensure report timelines are maintained and perform scientific reviews to ensure high quality study design and timely reporting
  • Ensure departmental policies, practices, and procedures adhere to regulations as they relate to the conduct of preclinical studies. Establish new policies and practices to ensure compliance with all applicable regulations and corporate policies
  • Participates in the review/and revision (as required) of standard operating procedures. Direct the development and communication of departmental systems, SOPs, policies, and procedures.
  • Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, take advantage of opportunities, and maintain state-of-the-art practices.
  • Works with Quality Assurance on regulatory updates of GLP requirements and Good Documentation Practices (GDP) as they apply to cell and gene therapy studies.
  • Collaborates with other divisions and departments to carry out the organization's goals and objectives, translates the strategy into actionable deliverables and ensures its execution per agreed timelines.
  • Works with the Business Development team to maximize US exposure to improve win rate of in vivo CGT opportunities
  • Collaborates with all US sites and divisions to integrate CGT capabilities with the goal of increasing efficiencies and opportunities with Clients
  • Performs other related duties as assigned
  • Direct the development and communication of departmental systems, SOPs, policies, and Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
  • Perform all other related duties as assigned.
Experience
  • A minimum of 12 years of experience in a GLP regulated environment in the biotechnology, toxicology, pharmaceutical, or related industries.
  • 7+ years representing a functional area relevant to this position, proven leadership track record, deep understanding of IND requirements and regional regulatory guidelines, in depth experience and knowledge of GLP and internal and external regulatory audits/inspections, proven people management skills, strategic planning and development experience.
  • Experience working in a matrix team across disciplines and departmental lines, and experience working in a global and multicultural organization.
  • Excellent written and verbal communication skills.
  • CRO experience is highly desired.
  • Ocular/Ophthalmology experience is highly desired.
Education
  • PhD in cell biology, immunology, pharmacology, toxicology, or a relevant scientific discipline.
  • Board Certification in Toxicology (DABT) is highly desired.
Benefits

Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
  • Medical, Dental & Vision Insurance Plan with Employer Contribution
  • Health Reimbursement Account Funded by Employer
  • Healthcare & Dependent Care Flexible Spending Accounts
  • Employee Life and AD&D Insurance 100% Employer Paid
  • Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
  • Long Term Disability 100% Employer Paid
  • 401k with Employer Match
  • Profit Sharing
  • Employee Assistance Program
About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.


This job has expired.

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