Executive Director Head of CMC Leadership

5 days ago

Novato, California, United States CLevelCrossing Full time
Job Title: Executive Director Head of CMC Leadership

About the Role:

We are seeking an experienced Executive Director to lead our CMC Leadership team. As the single point of contact for the entire CMC product portfolio, you will be accountable for the performance of all CMC product teams. This is a critical role that requires strong technical and leadership skills, as well as the ability to collaborate with cross-functional teams.

Key Responsibilities:

  1. Mentor and lead a group of 10 CMC Team Leads through both solid and dotted-line reporting relationships.
  2. Identify and address common issues affecting multiple CMC programs, from a technical, personnel, operational perspective.
  3. Ensure all CMC teams are functioning in a consistent manner using existing tools and processes or developing new ones as needed.
  4. Be the CMC representative at the Supply Review Meeting as part of the S&OP Process.
  5. Cultivate and maintain strong relationships with peers in other functional organizations, including Head of Product Quality Leaders, Head of Supply Chain Owners and Technical Development Leadership, to enable rapid and seamless cross-functional problem-solving.
  6. Work with the Head of CMC Operations to ensure that CMC team inputs into the portfolio planning and budget process are appropriate and timely.
  7. Take a leadership role in any portfolio-level activity prioritization discussions with TOPS leadership.
  8. Coordinate CMC portfolio plans with global company plans, internal manufacturing site production plans, contract manufacturing production plans, clinical development plans, CMC regulatory filings.
  9. Focus on continuous improvement of team capabilities by ensuring that partner team leads have the opportunity for training and development to excel in their role as functional representatives and cross-functional team members.
  10. Actively participate and potentially own the implementation of new processes and systems crafted to improve the efficiency and effectiveness of the CMC Leadership function.
  11. Work in close partnership with CMC Leads and CMC Project Managers to develop and present pipeline content including regular dashboards and program and portfolio reviews to the TOPS Leadership Team.
  12. Directly manage one or more CMC team in cases of extenuating circumstances (e.g. CMC product lead is on leave).
  13. Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals.
  14. Work closely with the Head of Early-Stage CMC to facilitate effective transition of early stage programs to full CMC management.
  15. Consider specific molecule, modality and therapeutic area to adapt development strategies when technical development gaps are identified during intake process.
  16. Maintain technical competence of all therapeutic modalities and their manufacturing and analytical schemes to facilitate productive engagement of the CMC product teams and gain trust of CMC Product leaders.
  17. Work with Head of CMC Technical Strategy to support application of CMC "playbook" by product teams via the use of technical maturity matrices, best practice documents, and technical stage gate reviews.
  18. Strong technical and regulatory understanding of the CMC concepts detailed in the documents and how they apply to different molecules will be critical for facilitation.
  19. Partner with Head of CMC Innovation and Technology to synthesize and articulate technical problems arising from CMC teams, such that the correct innovation targets are identified.
  20. Also work with the CMC leads to appropriately integrate any technology advancements once available, especially if relevance is at portfolio-level.
  21. Engage with WWRD and PPD organizations to address strategic, scientific, and technical issues that impede the success of the program portfolio.
  22. Participate in corporate governance as needed to support this objective.

Requirements:

  1. 10 years of experience in a technically oriented role; experience in process, analytical development or quality control is required.
  2. Demonstrated success in CMC Product team leadership; experience in early stage and/or clinical product teams is required.
  3. Ph.D. in Biotech, Chemical Engineering, Biology, or Chemistry or related field is highly preferred; additional/postgraduate qualifications (MBA, PMP, PMI) are a bonus.
  4. Outstanding project management skills, specifically timeline and budget development and oversight with experience at all phases of the product lifecycle.
  5. Experience leading a portfolio of multiple products, and prioritization of activities and resources.
  6. Proven proficiency and hands-on experience with typical CMC activities.
  7. Understanding of standard technical development strategies, cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.
  8. Applies technical and scientific expertise in project management and contributes to the development of new concepts, techniques and standards.
  9. Experience managing projects with remote teams and through external alliances preferred.
  10. Previous people management experience required along with a passion for employee development.
  11. Proactive and strategic problem solver, with strong facilitation, problem-solving and issue resolution skills.
  12. Highly collaborative with outstanding communication and relationship management skills, high emotional intelligence.
  13. Creates highly effective strategic vision and has a remarkable sense of how situations can unfold; prepares well in advance to take fullest advantage of the changing environment.
  14. Adept at balancing cross-functional interests in establishing operational strategies and identifying, resolving preempting operational challenges, risks and issues.
  15. Influences senior management and cross functional team on decisions regarding balance of quality and timeliness, taking into account activities across a project or portfolio of projects.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced leader looking for a new challenge, please submit your application.

Equal Opportunities Employer:

CLevelCrossing is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace and are an affirmative action employer. We are proud to be an equal opportunity workplace and are an affirmative action employer.

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