Director/ Sr. Director, CMC Strategy & Program Management

Our clinical-stage vaccine client is growing and looking to add a Director / Sr. Director, CMC Strategy & Program Management to their team! (Boston or Remote from Pleasant Hill, CA area) Operations program lead will be an integral part of the program team and will be responsible for managing activities across all Technical Operations (TO) functions. Reporting into company’s CTO, this individual will be the strategic focal point of the TO function, which encompasses manufacturing, supply chain, analytical development, research, process development and MSAT. They will partner closely with functional team leaders and senior management to ensure accountability for management, coordination and supervision of the programs. Will partner closely with functional heads to prepare project team and steering committee materials related to their assigned projects, anticipate and track project issues and risks. They will also drive development of appropriate mitigation plans with collaborate with functional leads for timely implementation of identified solutions. The candidate will also be involved in both incoming and outgoing business development projects. 

Responsibilities:
• Partner with TO leads to develop and execute the CMC clinical strategy across the portfolio.
• Work with CMC leadership to develop tools and mechanisms focused on defining prioritization, resource allocation and decision-making frameworks to ensure CMC achieves timelines and quality milestones.
• Prepare and deliver status updates for project review forums and communication to senior management.
• Work with CMC PMs to execute the strategy, align on project plans, manufacturing, scheduling, and clinical supply.
• Coordinate with Business Development and Finance function on partnering discussions and strategy; lead due diligence activities for TO
• Identify and implement best practices to facilitate standardization and coordination across disciplines, functions and/or programs.
• Proactively identify gaps/risks and work with internal teams to develop and implement mitigation plans/corrective actions and escalation pathways, which pose challenges to achieving strategic goals.
• Direct and effective project communication to ensure that all stakeholders (internal project teams and external partners) are fully informed and knowledgeable of project activities and their status.
• Drive innovative approaches related to data reporting, availability and transparency based on best-practice dashboards, metrics, and other relevant reporting mechanisms.
• Represent Technical operations and lead the cross-functional CMC project team with TD leads and CMC PMs to manage align on Tech Ops activities and timelines.
 

Requirements:

• Advanced degree in Life sciences and minimum 8+ years of relevant industry experience in management consulting, program management, or TO related roles. Ph.D strongly preferred.
• Extensive experience applying principles, concepts, practices, and standards of project management to drug development and manufacturing.
• Cross-functional leadership skills – proactive ownership, prioritize & execute, inspire creativity, drive accountability within teams.
• Proven results-orientation with strong influencing, problem solving, and negotiation skills.
 • Ability to work quickly, assess fluid situations, assimilate key data, recognize key variables, analyze complex situations, and make quality judgements.

Other:

  • Willingness to travel, sometimes with little notice, to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Up to 20-25% travel required.