Director CMC Strategy and Program Management

Location
Redwood City, CA, United States
Posted
Oct 29, 2020
Ref
142032069
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Director CMC Strategy and Program Management

Allakos, Inc. is a clinical-stage company developing therapeutic antibodies. Our lead drug candidate is lirentelimab (AK002), an investigational antibody that targets Siglec-8, an inhibitory receptor selectively found on mast cells and eosinophils. In clinical and preclinical studies, lirentelimab has been shown to broadly inhibit mast cells and rapidly deplete eosinophils. Lirentelimab has been tested in a Phase 2 randomized, double-blind, placebo-controlled study in patients with eosinophilic gastritis and/or eosinophilic duodenitis . The study met all pre-specified primary and secondary endpoints, including eosinophil reduction and symptom improvements compared to placebo and Allakos has initiated a registrational Phase 3 study in patients with EG/EoD . In preparation for commercial launch several CMC projects must be executed successfully to support this important drug. The Director of CMC Strategy and Program Management 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 the Director will also have responsibility to support additional CMC projects and initiatives as they arise.

The Director of CMC Strategy and Program Management reports directly to the Vice President of Technical Operations supporting strategic planning and execution of near and long term corporate goals. The Director will play a key role in integrating work across complicated projects with aggressive timelines. This role will require a candidate who is comfortable working collaboratively with technical teams who also enjoys providing hands- on program management support for successful execution of project plans.

Primary Responsibilities
  • Work closely with the VP of Tech Ops to capture and establish CMC product development strategy
  • Establish "right -size" and scalable business processes for Technical Operations
  • Think holistically and strategically about all aspects of business operations, key operational rhythms, business processes, procedures and enable effective execution
  • Support the multifunctional CMC Teams, with responsibility for developing integrated strategic and tactical plans, and tracking performance relative to plans.
  • Communicate project plans to Technical Operations and Company Management
  • Assure that the plans will adequately address global health authority expectations; including project management support of BLA Module 3 writing.
  • Serve as a major communication link in a matrixed organization and ensure the departments are adequately informed and are resourcing appropriately
  • 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 VP for various forums

Qualifications
  • 15 years of experience in a biopharmaceutical environment
  • 5 years of experience in Project Management (PMP certification a major advantage)
  • Proven track record in CMC leadership
  • Demonstrated ability to influence executive leadership on complex business topics
  • Demonstrated understanding of the elements required for successful regulatory CMC submissions
  • Excellent communication, 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.