Director, Regulatory Program Management (BLA Leader)

Location
Redwood City, CA
Posted
Oct 12, 2021
Ref
4144717004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Director, Regulatory Program Management (BLA Leader)

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.

The Director, Project Management is responsible for leading lirentelimab’s BLA process and will report to the Senior Vice President, Strategy & Operations. The Director will have had recent ‘hands on’ experience in Biotech and/or Pharma leading to a FDA BLA submission.  The Director will be well-versed in current FDA regulations, policies, and guidelines.

Position Summary:

  •  Lead Lirentelimab’s BLA process working with Head of Regulatory, functional leaders, other project managers, and presenting status updates and action plans to the executive team.
  • Organize an over-arching approach to the BLA, set timelines, track progress, identify issues, and work with functional colleagues to ensure an on-time and successful submission of the BLA.
  • Develop strong and productive working relationships with key stakeholders throughout the Communicate effectively to ensure an effective understanding of regulatory science and compliance.


Your Role:

  • Creates and implements regulatory strategies for BLA submissions.
  • Proactively partners with the Head of Regulatory on the development of the regulatory strategy as well as Clinical/Nonclinical counterparts on process and program prioritization.
  • Coordinates strategy for CMC with Regulatory colleagues.
  • Provides proactive guidance to internal groups on strategic and tactical plans based on regulatory knowledge. Identifies and assesses regulatory risks.
  • Provides guidance to all appropriate departments to assure compliance with applicable regulations.
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate.
  • May supervise Regulatory Affairs team members.

Qualifications and Expertise:

  • BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
  • Successfully prepared and filed a BLA, preferably for a monoclonal antibody or therapeutic protein.
  • 10+ years of Regulatory and/or Project Management experience as well as additional experience in the biopharmaceutical industry in other areas.

The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.