TITLE: Director/Senior Director, CMC Program Management

POSITION SUMMARY:

This position will be responsible for providing CMC Project Management expertise and support to ensure all project milestones and deliverables are met, and that Adicet Bio CMC program activities are well executed and managed. Responsibilities include partnering with CMC Technical Leaders and the Chief Technical Officer (CTO) to create and manage execution plans in alignment with the strategic Product Development Plan and estimated budget. This CMC PM senior professional will foster a collaborative team environment and is responsible for the management of multiple project activities to achieve CMC milestone commitments to the Company’s programs and products. This role is expected to understand and utilize in-depth knowledge of underlying Technical Operations functions (Process Development & Validation, Analytical Methods Development & Validation, Manufacturing Operations, Quality Control, Supply Chain, Regulatory Affairs, Quality Assurance), business strategies, and the company’s goals required to make decisions or resolve issues. This role will effectively manage cross functional teams to plan, prioritize, develop, and execute timelines in partnership with internal stakeholders and the Company’s Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs). This role requires the ability to interpret and integrate complex information; appreciate cultural differences in CMOs and CTLs to establish and maintain relationships; effectively predict and, where necessary, efficiently execute against strategy changes or unexpected events; clearly communicate with internal and external stakeholders; and obtain agreement from multiple parties and influence others without direct authority.

RESPONSIBILITIES:

• Partners with Tech Ops technical leaders and the CTO to optimize team effectiveness and decision making, and to develop a detailed CMC project plan and associated budget. 
• Creates and drives CMC timelines to keep program(s) on schedule. Prepares detailed CMC timelines (Gantt chart) identifying all significant activities, dependencies, resources, and milestones. Assists the Tech Ops technical leaders in planning, coordinating, and tracking cross-functional and external CMO and CTL activities for the Adicet Bio program. Continual review and analysis of critical path activities.
• Facilitates highly effective team building and communication. Works with the Tech Ops technical leaders to develop and distribute agendas for regular team meetings. Helps facilitate meetings and keeps them on track. Provides meeting minutes and drives follow up on Action Items. Proactively, and independently, identifies and resolves CMC team challenges.
• Performs effective risk management assessments with the CMC team, Tech Ops technical leaders, the CTO, and other stakeholders.
• Drives information flow and communicates CMC program status to all stakeholders in collaboration with the CTO and Tech Ops technical leaders. Produces regular status reports (milestones, status, issues, decisions), following review by the VP Program Development, Program Leader, Program Team, Tech Ops technical leaders, and CMC Team for executive and senior management.
• In partnership with the Program Leader, Tech Ops technical leaders, and the CTO, ensure that the CMC Team provide continuity of drug supply for regulatory filings and clinical studies and resolves issues and organizes team to execute on corrective actions.
• Develop, manage and maintain the contractual relationships and project interfaces with CMOs and CTLs

• Utilizes project management tools and techniques to drive the establishment of CMC team strategic objectives and CMC goals that support company goals.
• Consolidates and reports on CMC program budget. Works with the VP Program Development and the Tech Ops functional areas to prepare the annual (and longer range) program budget. Provides budget forecasts as requested.
• In cooperation with Tech Ops functional managers, ensures that resources assigned to the CMC program are adequate to meet objectives and identifies resource constraints.
• Maintains effective communication with the CMC Team through oral and written correspondence and ensures adequate documentation of each communication. 
• Creates and maintains an appropriate electronic platform for reporting and documentation of relevant program information, records, etc. 
• Interfaces internally by acting as a liaison and facilitator of Tech Ops cross functional teams (ie, Process Development & Validation, Analytical Methods Development & Validation, Manufacturing Operations, Quality Control, Supply Chain, Regulatory Affairs, Quality Assurance) in planning and executing on CMC deliverables.
• Interfaces externally with CMOs, CTLs, and other collaborators, vendors, contractors, and consultants to ensure communication and CMC deliverables in accordance with planned CMC program objectives.
• Serves as a resource for other CMC Program Managers as appropriate. May manage other junior CMC Program Management staff.
• Contributes to the development of the Program Development Department through introduction of new tools and processes for continuous improvement.

QUALIFICATIONS:

• Advanced degree (PharmD, PhD) is desired but not required.

• 10 years of work experience within industry, 8 years of Program/Project Management experience, within a matrixed pharmaceutical or biotechnology organization. PM Certification is a plus.
• 8 years of experience working with CMOs and CTLs and leading cross-functional project team

• Oncology experience is highly desirable.
• Cell therapy experience is highly desirable.

• Proactive mindset with strong leadership, facilitation, teamwork and influence management/negotiation skills. 
• Excellent verbal and written communication skills as well as exceptional organizational capability.
• Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
• Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
• Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Familiarity with developing budgets and forecasting is highly desirable.
• Keen insight, independent judgment and tactful discretion are required. 
• Must be able to demonstrate strong analytical and problem-solving capabilities.
• Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
• Travel to US and international CMO and CTO sites may be required

Benefits

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.