Sr. Manager / Associate Director, CMC Project Management
We need you to help take 4D to the next level!
In this highly visible and important role as Sr. Manager/Associate Director, CMC Project Management, you will report directly to the Chief Technical Officer, with dotted line reporting to the Head of Program Management Function. This is your opportunity to shine -- your chance to design and implement PM strategy, to work not just in 1 therapeutic area, but multiple therapeutic areas across a product platform that spans all different phases of the program. Excitement and growth permeate 4D Molecular.
You will be a member of the core program team representing CMC and will partner with Pre-clinical and Clinical development teams and other non-CMC project managers in the development and implementation of CMC project strategies and comprehensive project plans.
- Lead CMC team in establishing clear scope of work and drive team towards the delivery of project milestones on time, on budget, and within scope through utilization of project management tools.
- Lead the CMC team to:
- Identify CMC project objectives
- Build fully integrated project schedules capturing all activities and resources needed to deliver the against corporate goals
- Identify measurable success criteria
- Monitor project progress and identify risks and opportunities to timeline, budget or scope
- Ensure adequate plans are in place to mitigate risks and enable opportunities
- Effectively communicate progress at all levels and escalate critical issues appropriately
- Ensure project sub-teams apply the techniques stated above to their planning
- Assist CMC leadership with management of the CMC budget by monitoring actuals to plan and forecasting
- Support CMC planning for regulatory filings
- Facilitate and incorporate lessons learned and best practices
- Coordinate and lead internal and CMC-Vendor meetings, and document and communicate key takeaways to relevant constituents
- A minimum of 8 years of experience in the biotech/pharmaceutical industry including project management in drug development and operational planning. Experience with early to late-phase projects are strongly preferred.
- A minimum of 5 years of Project Management experience (for the Associate Director position, a minimum of 2 years in PM leadership role is required)
- A minimum of 2 years of experience within a CMC function or group with hands on experience in pre-Clinical/Clinical phase drug product development or 2 years of specific CMC project management experience with a complex biologics manufacturing development processes (gene and cell therapy experience is highly desired)
- Proven project management skills
- Superior written and verbal communication skills
- Strong organizational skills and attention to detail
- Strong knowledge of team dynamics, structure, roles and responsibilities
- Excellent ability to embrace ambiguity and complexity and demonstrate problem solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks
- Ability to respond quickly and effectively to changing environments
- Demonstrated ability to manage and lead others through change
- Demonstrated ability to influence outcomes and key project decisions without authority
- Ability to work both independently and in a team focused environment
- Skilled facilitator and negotiator with a keen eye for detail
- Some US and international travel required (less than 10%)
- Bachelor of Science degree in Life Sciences, including but not limited to, Chemistry, Molecular Biology, Human Genetics, Immunology, Virology, Chemical Engineering, Mechanical Engineering, or related discipline.
- Advanced degree (MSc, PhD highly desirable)
We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT’s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.