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Associate Director, Program/Project Management

Cambridge, MA 02142

Post Date: 07/02/2018 Job ID: 1974 Job Category: Clinical: R&D Program Management

This individual will work closely with internal cross-functional teams to ensure execution of the strategy managing specific projects/programs, and facilitating all stakeholder communication. The ideal candidate will have a scientific background, experience with drug development and operations. This role is highly cross-functional, and will involve close interaction and collaboration with external partners. The individual should possess an in depth understanding of cross-functional R&D projects, and will be responsible for creation of project plans, identifying and tracking critical path/activities, risks, contingencies and alternatives. The Associate Director/Director, Program /Project Management will proactively manage daily program/project management activities, including schedule development by function and integration across projects and programs, budget, communication, status reporting, and resource plan development for certain selected larger projects. The ideal candidate will drive alignment to overall priorities, objectives, deliverables, interdependencies and timelines to remain on track by executing against pipeline strategic plan.

Responsibilities:
  • Serve as project manager for drug development teams with focus on PMO platform and Gene Therapy, providing leadership, coordination, and cross-functional communication to enable teams to meet their aligned goals through improved, cross-functional decision making
  • Lead cross-functional program teams (for multiple drug candidates), including representatives from clinical, nonclinical, regulatory, and CMC, to execute on the drug development strategy
  • Identify and track all CMC projects requiring cross-functional support
  • Provide focus for the cross-functional team through visibility to an integrated project plan to ensure all stakeholders are aware of key program activities; to frame important strategic and tactical issues and contingencies; and to ensure timely decision-making
  • Work closely with all team members to apply project management processes such as definition, initiation, planning, execution and risk management.
  • Integrate Analytical Chemistry, Process Development, Manufacturing, Supply Chain, Clinical, Quality, and Regulatory requirements and constraints into overall project plans
  • Lead data-driven decision-making in order to make solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, and change management recommendations.
  • Develop and maintain detailed program milestones and timelines, proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans
  • Facilitate team meetings to drive cross-functional communication, decision making, and successful execution of program and accountability to commitments and timelines
  • Apply Project Management best practices, from development of agenda, to distribution of meeting summaries, to follow up of all relevant action items
  • Proactively identify opportunities for improvement to team effectiveness, processes, communication and/or program outcomes
  • Report on program progress/change and elevation of issues/delays, as appropriate, to management
  • Ability to draft slide decks and dashboards for program strategy reviews, Executive, and BoD updates.
  • Understand and leverage inter-department dependencies and handoffs
  • Foster strong relationships with team members and functional line managers, and serve as key point person for program team members on project-related communications and issue identification and management
  • Program budget tracking (together with finance representative), including approval of changes that arise throughout the year due to changing conditions/plans within the program


Qualifications/Requirements:
  • BS in technical discipline, Advanced degree preferred
  • 5-10 years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, regulatory affairs or project management with significant exposure to global teams
  • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, financial investment, manufacturing and organizational capacity) to achieve aligned corporate objectives with a “ sense of urgency”
  • Self-directed individual who is able to work independently with limited direction while working successfully in a cross-functional environment.
  • Must be a solution-based, creative thinker with a “ can do”/” do-what-it-takes” attitude and superb organizational and communications— both written and oral
  • Demonstrated leadership in clinical-stage drug development settings with strong analytical skills and entrepreneurial drive
  • Highly collaborative team player who fosters open communication, facilitates mutual understanding and cooperation with all stakeholders
  • Strong interpersonal skills with the ability to motivate others, to direct activity from a position of informal influence, to negotiate conflict situations, and to forge consensus between competing points of view
  • Must have the ability to work well as part of a team in a fast paced environment and foster open communication, mutual understanding and cooperation within the company and with external vendors
  • Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS, etc.
  • PMP certification preferred

Dorie McCrann
Senior Clinical Recruiter

Dorie is a great listener who connects easily with candidates and clients. She brings 18 years of full life-cycle recruiting experience to The Steely Group, and attributes her success to a customer-focused approach, attentive communication, and strong networking skills.

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