Associate Director in Palo Alto, CA at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

  • Employee Type:
  • Location:
    Palo Alto, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Apex Life Sciences is seeking an Associate Director of Regulatory Affairs who will be responsible for overseeing and implementing Regulatory Affairs strategies and activities relating to all investigator-initiated INDs, from initial filing for clinical trials in the setting of an academic research organization and for a cGMP (current Good Manufacturing Practice) facility. The position will assist in the development and implementation of regulatory strategies for interacting with regulatory agencies, will act as liaison with the FDA, NIH-OBA, and institutional regulatory committees. This position will provide staff expertise and preparatory assistance to Regulatory Affairs management in preparation of documents for Regulatory submissions to the FDA for assigned clinical trials. This role is collaborative in nature and interacts regularly with all other functional groups including Process Development & Manufacturing, Quality Systems, Operations and Finance & Administration. 

Duties include:

• Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
• Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
• Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
• Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
• Develop policies and procedures as they relate to academic or program activities.
• Implement, evaluate and maintain quality control standards to ensure program success.
• Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
• Recommend the adoption of emerging technologies and the development of new methods and approaches.
• Negotiate with internal departments and external agencies with authority to commit resources and effort.
• Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.

• - Other duties may also be assigned

Advanced degree preferred and demonstrated expert knowledge & up-to-date familiarity with regulations pertaining to INDs involving CBER and ICH guidance including experience with CMC development in cell and gene therapy.

Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.

• Experience leading, managing, motivating and developing technical staff.
• Experience leading complex scientific, engineering or technical research projects or programs.
• Detailed understanding of relevant business and technical knowledge and problem resolution.
• Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
• Knowledge of emerging technologies, trends, methodologies, and resource management principles.
• Demonstrated ability to work and communicate effectively with others.
• Exceptional customer relationship and consensus building skills.
• Ability to influence and establish effective working relationships in a diverse environment.
• Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.