Senior Director, CMC Supply Operations - Job #1003 - Redwood City , California, United States, 94059
The Senior Director, CMC Supply Operations, is an end-to-end global supply chain leader that inspires teams while providing expertise in a fast-paced biotech environment. The Senior Director mentors the Supply Chain & Logistics and CMC Project Management groups and works collaboratively with Biological Development and External Manufacturing, Regulatory, Quality Assurance, Commercial, and Clinical Operations to develop strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the global supply chain from the protocol design through production planning, inventory management and distribution of clinical supplies at clinical sites worldwide. Under the leadership of the VP, Technical Operations, the Sr. Director builds resilience and secures supply or quality product to patients, plans for and manages commercialization after initial approval, product launches and global product security.
- Provide leadership and direction to the CMC Project Management and Supply Chain & Logistics teams through establishment of goals, plans and performance metrics that are periodically reviewed & reported to the Head of Technical Operations.
- Designs and owns the E2E business processes for clinical supply chain management and ensures the IT system roadmap enables those processes in an integrated manner
- Identify risks and assumptions in plans, anticipates problems and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track.
- Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement
- Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes
- Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships with minimal resources.
- Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
- Highly skilled in the ability to work with ambiguity and complexity, and can continuously modify options and solutions across all levels of the organization.
- Must possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.
- Works well with ambiguity, can assess options quickly and efficiently and implement best option in alignment with Allakos culture and expectations.
- Foster a culture of cross-functional collaboration, objective self-analysis and transparent collective ownership of outcomes. Develop team members.
- BS/MS/Ph.D. in life science or engineering and at least 20/17/15 years of related experiences in the biotechnology or pharma industry
- Energetic, flexible, collaborative, and proactive leadership and management skills to grow and develop the CMC Supply Operations team
- Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders
- Long range planning in alignment with both product and network strategies - determine what mix of inventory, capacity (dual sourcing) or lead time buffers are needed to secure supply
- Manages product switches and transfers in alignment with the product strategy, including clinical to commercial transitions
- Strong planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management
- Excellent judgment and creative problemsolving skills, including negotiation and conflict resolution skills
- Able to work in a fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables
- Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
- Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution.
- Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (up to 10%), domestic and international
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to and reference Job #1003
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.