4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a global leader in gene therapy product research and development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4DMT, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus (AAV) variants platform to treat serious unmet medical conditions. 4DMT is in need of a motivated and experienced Sr. Manager/Associate Director, CMC Project Management
The CMC Project Manager will be a member of the core program team representing CMC and will partner with the Pre-clinical and the Clinical development teams and other non-CMC project managers in the development and implementation of CMC project strategies and comprehensive project plans.
This role will report directly to the Chief Technical Officer with dotted line reporting requirement to the Head of Program Management Function.
Specific responsibilities include (but are not limited to):
- 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 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)
Qualified candidates may submit their resume and cover letter to firstname.lastname@example.org