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 Project Manager to support Bioanalytical scientific activities.
Specific responsibilities include (but are not limited to):
- Establish and maintain mechanisms to track progress and completion of in-house and CRO deliverables and obligations for analyzing preclinical and clinical development activities for all therapeutic candidates.
- Manage CRO site relationships and resolve issues of moderate to high complexity.
- In a matrixed environment, interface with Product Leader(s), Scientific leads and Department Heads in prioritizing assigned project support activities.
- Create and maintain project/program plans, timelines, agendas, budgets, resourcing requirements, rolling summaries and other tools to facilitate planning and coordination of deliverables for the project/program.
- Manage all aspects of program/project team meetings in the assigned therapeutic area(s) as it pertains to in vivo pharmacology, toxicology, biomarkers and bioassays. This might include developing meeting agendas, maintaining meeting minutes, developing presentations and proposals, and any other necessary content.
- In collaboration with Scientific Lead, deliver project/program updates to project team and/or to senior leadership as necessary and appropriate.
- Work closely with Product Leader to identify areas of program risk and collaborate with project team to propose risk mitigation strategies.
- Under the direction of the Department Head and assigned Scientific Lead, develop Requests for Proposal for outsourced preclinical development activities. Manage the proposal process and present proposal summaries to the project team to inform contract awards.
- Under the direction of the Department Head and assigned Scientific Lead, manage contracts with CROs for outsourced activities, including contract changes, issue resolution, contract clarifications, and study reports.
- BA or BS degree required; Master’s or other advanced degree preferred.
- A minimum of five (5) years of experience in the life sciences and/or biotech/pharmaceutical industry. Prior bioanalytical assay experience is a plus.
- The ideal candidate will have experience in project management, operational planning, and/or contracts management. Experience with IND regulatory submissions and/or Phase 1 clinical trials is particularly desirable.
- Practical working knowledge of project management techniques and concepts as they apply to the biotech/pharmaceutical industry.
- Previous experience managing outsourced contracts and success at documenting and administering the contract terms and requirements.
- Keen attention to detail; exceptional organizational skills.
- Excellent written and oral communication skills.
- Must be able to work independently and within team environments.
- Ability to prioritize tasks, adapt to shifting priorities, and deliver on projects in a timely manner.
- Ability to capture technical discussion in the form of meeting minutes, decision points and action items.
- Experience working in cross-functional product development teams and in particular in a scientific or clinical setting is desired.
- Ability to confidently and respectfully interact with all levels of management.
- Experience in regulatory affairs, clinical operations, and/or manufacturing is additionally desirable.
- Proficient in relevant software: MS Project or other project management software, Excel, PowerPoint, Word, Access, etc. in addition to general knowledge with shared work environments.
Qualified candidates may submit their resume and cover letter to firstname.lastname@example.org