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Director, CMC-Project Management

Norwood, MA 02062

Posted: 08/09/2019 Employment Type: Direct Hire Job Category: Clinical: General Job Number: 2418

The Director, CMC-Project Management  provides comprehensive project management support for internal, cross-functional teams to ensure clarity of strategy, to manage specific product development and regulatory submissions (e.g., IND, IMPD, NDA, MAA), in order to advance pipeline programs on behalf of our client.  This role is highly cross-functional and will involve close interaction with external partners. The Director is charged with having an in-depth understanding of critical path/activities and interdisciplinary CMC connections necessary for technical and regulatory success. This role manages the operational plan and project deliverables so that they are achieved on or ahead of schedule, on budget, with quality that meets or exceeds business needs.

Primary Responsibilities Include
  • Build, drive and maintain project and major regulatory submission plans that delivers tangible results in advancing the company’ s pipeline, ultimately leading to commercial launch of key assets.
  • Facilitate team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions.
  • Develop and maintain detailed program and major regulatory submission milestones and oversee the process for content draft, review and delivery according to identified timeline proactively identify and prioritize program risks and develop and monitor risk mitigation/contingency plans.
  • Oversee adherence to program budgets and regulatory submission project plan timelines and deadlines.
  • Manage inter-dependencies across functions, between CMC and clinical, non-clinical, quality, regulatory to support execution of project plan and major regulatory submissions.
  • Lead data-driven decision-making in order to make timely, solid, objective recommendations for continuation, acceleration, re-prioritization, redesign or termination of projects, along with necessary change management recommendations.
  • Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables.
  • Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments.

Education And Skills Requirements
  • BS in technical discipline, advanced degree preferred.
  • 10+ years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, or regulatory affairs with significant exposure to global teams.
  • 5+ years of experience in program management/leadership of cross-functional teams with demonstrated ability to drive projects to completion.
  • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, investment, capacity) to achieve aligned corporate objectives with a sense of urgency.
  • Self-directed individual who can work both independently and through a cross-functional team in a fast-paced environment, fostering open communication, mutual understanding and cooperation within the company and with external vendors.
  • Solution-based thinker with a “ can do”/” do-what-it-takes” attitude, coupled with superb organizational, influencing, and communication skills.
  • Strong interpersonal skills with the ability to motivate others and direct activity from a position of informal influence, negotiate during conflict situations, and forge consensus between competing points of view.
  • Fluency with standard computer software packages (MS Project, Word, Excel, PowerPoint, PMIS).

 

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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