CMC Regulatory Affairs Project Manager/Senior Project Manager

Adicet is developing the next generation immunotherapies by generating a pipeline of allogeneic gamma delta T cell products engineering with CAR or TCR. In addition,
Adicet's immune cell platform is complemented by its ability to identify and validate novel disease specific peptide-MHC targets and generates T cell receptor-like antibodies directed against these disease-specific peptide MHC complexes.

Adicet Bio was founded in late 2015 with significant investment from OrbiMed, Novartis Venture Funds and Pontifax. In August 2016, Regeneron and Adicet Bio announced a strategic collaboration to discover and develop next-generation engineered immune-cell therapeutics and in September 2016, Adicet Bio was recognized and named by FierceBiotech as a "Fierce 15" Biotech Company of 2016.

CMC Regulatory Affairs Project Manager/Senior Project Manager

Adicet is seeking an experienced Project Manager to join the Project Management Team.

The CMC Regulatory Project Manager / Sr. Manager works collaboratively with CMC team leaders, CMC teams, Clinical Operations and Regulatory Affairs towards achieving project goals by providing project management expertise. The primary responsibility of this role is to manage the CMC project schedules with a focus on effective planning, coordination and execution of activities, and communication. The objective is to ensure smooth and efficient operational implementation of CMC strategy, including clinical trial supply and timely preparation and submission of regulatory filings. In this role the CMC Regulatory Project Manager / Sr. Project Manager will manage CMC internal activities for specified projects at all development stages, interfacing with relevant functional groups. The CMC Regulatory Project Manager / Sr. Project Manager will facilitate CMC and Regulatory Team meetings and be responsible for efficient conduct and follow through. The CMC Regulatory Project Manager / Sr. Project Manager will be expected to use key project management tools to plan and track project deliverables and facilitate communication of regulatory activities across CMC Subteams and Senior Management. The Project Manager will attend and coordinate CMC regulatory meetings and will be responsible for maintaining timelines, meeting minutes, action items, resource plans and other project documents. The CMC Regulatory Project Manager / Sr. Project Manager will also interface with other project managers to integrate CMC plans with overall plans and ensure planning, coordination and communication to enable timely supply of materials and information of the required quality standard.

The successful candidate will contribute to the advancement of Adicet's Immune Cell Product pipeline in close collaboration with the rest of Adicet's talented and versatile team.

Key responsibilities:

• Under minimal managerial direction, manage the development of the CMC content of submissions to world-wide regulatory applications (eg, IND, CTA, BLA, MAA, and associated amendments) and ensure applications consistently meet Adicet's high standard and team timelines for submission to health authorities.
• In partnership with Regulatory Affairs, work to direct regulatory CMC strategy on complex issues, proactively identify possible development problems and identify possible mitigation strategies, and effectively resolve issues when they occur.
• Assist in establishing, implementing, and managing submission/regulatory information trackers for assigned programs.
• Assist in coordination of regulatory CMC agency meetings and preparation of meeting materials.
• Maintain awareness of changes in the regulatory space and distribute newly issued regulations/guidance within Adicet.
• Coordinate and facilitate communication among members of project teams to ensure effective, accurate, and timely collaboration across functional areas.
• Facilitate team and subteam meetings where appropriate; compile and distribute minutes to all project team members.
• Establish and maintain mechanisms to track progress and completion of action items by the team.
• Coordinate and monitor activities in compiling regulatory reports or presentations.
• Provide overall support for project team meetings and teleconferences (e.g. room booking, calendar management, conference call setup, etc.).
• Prepare, organize, and maintain departmental documents and historical files.
• Assess project issues and develop streamlining solutions to optimize and enhance the current project structure.
• Assist with the development of team dashboards and maintain on team's behalf.
• Maintenance of project Gantt timelines.

Professional experience/qualifications:

• Bachelor's Degree required, with a focus in science and/or business.
• Experience in the pharmaceutical or biotechnology industry is a must, cell therapy experience is a plus
• The ideal candidate will have 3+ years (5+ years for Senior Project Manager) pharmaceutical Project Management experience, with focus on CMC and Regulatory Affairs
• Experience in preparation and submission of IND applications

Skills:

• Ability to work both independently and in a cross functional and matrix setting
• Proven ability to work in a team setting and manage relationships to ensure successful achievement of deliverables
• Proven ability to proactively lead team meetings
• Proficient in relevant software: Excel, PowerPoint, Word, SharePoint in addition to general knowledge with shared work environments. Experience with Microsoft Project is a plus
• Advanced troubleshooting skills
• Proven track record of consensus building and conflict management in challenging situations
• Excellent interpersonal skills and professional demeanor
• Excellent written and oral communication skills
• Ability to anticipate and solve issues in a timely fashion
• Ability to work cross functionally with a variety of groups and personality types
• Team player
• Agile learner

BENEFITS:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.