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Manager/Senior Manager, Program and Alliance Management
4 months ago
Who We Are:
EvolveImmune Therapeutics is a next-generation, development-stage immune-oncology company which is developing novel trispecific T cell engagers with integrated CD2 costimulation to optimize anti-tumor immunity to overcome the therapeutic challenges of cancer cell resistance. Our lead program based on our EVOLVE therapeutic platform will enter the clinic in 2025. We conduct our R&D, including internal protein engineering and biotherapeutics discovery, immunobiology and translational sciences at our dedicated, state-of-the-art laboratories located in Branford, CT.
The Role
We are seeking an experienced, highly motivated and resourceful individual to support our Program and Alliance Management function. The successful candidate will work directly with the Senior Director, Program and Alliance Management to advance development programs from preclinical through early clinical development, including our lead EV-104 program. The individual will support integrated project planning, the development and oversight of budgets and timelines as well as other program development needs. Strong collaboration and communication capabilities, attention to detail, a can-do attitude, and prior development-stage experience in at least one area of development (clinical, CMC, or regulatory/quality) is required. Experience with Excel, tracking tools to create Gantt charts using MS Project, SmartSheet or other program management tools is preferred.
Responsibilities
- Support operational matters for development projects and external R&D or clinical collaborations by defining and implementing project schedule and timelines, tracking milestones, financial tracking, and providing status reports.
- Maintain all relevant documentation, schedule meetings, develop agendas, take sponsor notes/minutes and tracking follow-up activities of external resources.
- Establish and maintain a tracker to create visibility and maintain transparency into development activities to key stakeholders that contribute to the overall clinical development plan (e.g., Smartsheet, MS Project, Power Point).
- Depending on experience, support preparations for early clinical programs.
- Depending on experience support quality management.
- Ensure compliance with all health and safety protocols.
Qualifications
- Minimum of 5+ years of experience in biopharma with a PhD or 6-10 years as a BA/MS in Life Sciences (Biotech or Academic medical research setting) with 4+ year experience in a regulated functions such as clinical, CMC, or regulatory/quality in a biopharma setting.
- Knowledge of ICH/GCP/GLP or GMP and applicable regulations.
- Provide strong collaboration, coordination, and communication to support cross functional interactions, prioritization of activities, and ensure compliance to meet demands across early development in line with program priorities (i.e., translational teams, clinical CROs, vendors, data management, biostatistics, operations lead as relevant for the program).
- Well organized and able to work independently, capable of dealing with ambiguity to identify a path forward, strong attention to detail. Escalate risks and deficiencies as required.
- Ability to utilize and learn technical proficiency in the use of project planning tools and systems, and in MS Office software.
- Basic Financial Knowledge- must be able to work with financial tracking tools.
- Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global).
- Experience managing electronic TMF, including set-up, maintenance, QC/ QR and query management and familiarity with DIA reference model helpful but not required.
- Ability and willingness to travel to the office as needed.
EvolveImmune provides a competitive compensation and benefits package.
EvolveImmune Therapeutics, Inc. is an equal opportunity employer.
