Associate Director/Director CMC Strategy and Program Management

Location
Redwood City, CA, United States
Posted
Feb 23, 2021
Ref
142032069
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Associate Director/Director, CMC Strategy and Program Management

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.

Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

Job Description:

As Associate Director/Director of CMC Strategy and Program Management, you will serve a key role in setting strategy, establishing business processes and supporting the team during the preparations. The initial focus will be on launch of lirentelimab but will also have responsibility to support additional CMC projects and initiatives as they arise.

The Associate Director/Director of CMC Strategy and Program Management reports directly to the Head of CMC Strategy and Program Management supporting strategic planning and execution of near and long term corporate goals. The incumbent will play a key role in integrating work across complicated projects with aggressive timelines. This role will require working collaboratively with technical teams as well as providing hands- on program management support for successful execution of project plans.

Responsibilities
  • Work closely with the Head of CMC Strategy and PM to capture and establish CMC product development strategy, business operations and product lifecycle management
  • Execute on "right -size" and scalable business processes established for Technical Operations
  • Maintain the integrated strategic and tactical plans, and routinely track performance relative to project plans.
  • Partner with the CMC Team Lead and be accountable for the review cycles of BLA Module 3 sections, in collaboration with Regulatory Affairscounterpart
  • Serve as the major communication link to Finance organization for quarterly / year- end closes and budgeting
  • Focus on continuous improvement and operational effectiveness by proactively identifying issues and implement appropriate and timely mitigation plans
  • Organizes, plans and chairs the quarterly Manufacturing Ad Board meetings. Drives the agenda and sends out pre-reads
  • Prepare presentations for the Head of Tech Ops for various forums
  • Serve as PM for new IND programs


Qualifications and Expertise
  • 8+ years of experience in a biopharmaceutical environment
  • 5+ years of experience in drug development and 3 years of experience in Project Management (PMP certification a major advantage)
  • Proven track record in CMC leadership and business operations
  • Demonstrated ability to influence Technical Operations leadership on complex business topics
  • Demonstrated understanding of the elements required for successful regulatory CMC submissions
  • Excellent communication, time and project management skills and ability to champion the CMC strategy


The salary is competitive and commensurate with experience and qualifications.

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.