Director/Senior Director, Late-Stage Program Management

Generate BiomedicinesSomerville, MA
1d$177,000 - $266,000Onsite

About The Position

The Role: Reporting to the Head of Program Management, Generate:Biomedicines is seeking a motivated, proactive and action oriented Director/ Sr. Director to act as a “COO” for our most advanced program GB-0895 that recently commenced multiple Phase 3 trials across multiple indications. This is a critical role interfacing across multiple cross functional leaders to enable efficient and comprehensive execution of the goals, objectives and strategy of this program. The successful candidate will work in partnership with the CMO of I&I and the cross-functional Program Team to enable translation of the program strategy to a tactical plan for execution. The successful candidate will have strong program management, leadership and drug development experience in late stage clinical development and BLA submissions. Experience across other stages of discovery and development would also be valued. The Director/ Sr. Director must thrive in a fast-paced, ambiguous, highly interdisciplinary entrepreneurial environment, and have the desire to tackle large challenges. Here's how you will contribute: This role partners with the CMO I&I in their role as the strategic partner and operational lead for Generate’s Immunology Phase 3 program GB-0895 The Director/ Sr. Director will develop, maintain and control the integrated program timelines at the program team level. This includes the tracking of progress (baseline vs. latest estimate) made on key activities, tasks, deliverables, milestones and stage gate decisions; owning of scenario planning relative to scope, time, cost impact as part of effective decision making; identify activities on the critical path; and communicating the status of the program to key stakeholders. Individual will demonstrate creativity and resourcefulness in identifying, monitoring and mitigating risks and issues such that development programs execute according to plan. Building relationships with key stakeholders (program leader, functional team members and leadership) to ensure alignment of program, functional and company objectives to deliver the program strategy and promote program goals. Coordinating the program team’s day-to-day communications, including, facilitating cross-functional team meetings, leading discussions to drive decision-making, scenario planning, preparing agendas and meeting minutes, defining and resolving risks and issues. Partnering with Finance to develop and track program budgets and resource plans Providing oversight of third-party vendor activities and strategies which include status of vendor deliverables and third-party vendor metrics data. Supporting R&D processes as they relate to vendor operational qualification/documentation and vendor performance management Investing time in coaching, mentoring and acting as a role model for other program managers to enhance their skills and performance at a higher level.

Requirements

  • Bachelors degree in life sciences or business-related field; PhD and/or MBA preferred.
  • 12+ years biopharma industry experience, including minimum of 8 years with direct program management experience in biotechnology or pharma industries, is required. Flexibility to consider director or senior director level depending on ones relevant experience.
  • Experience with program management of late-stage (Phase 3) clinical programs and BLA submissions, is required
  • Outstanding interpersonal skills with a demonstrated ability to build alignment and drive resolution of issues while maintaining positive working relationships across functions
  • Ability to effectively apply program management principles including, but not limited to, identifying critical paths, building and communicating timelines, defining milestones and methods for setting expectations and accountability.

Nice To Haves

  • Project/program management certification
  • Experience in Immunology indications
  • Excellent written and verbal skills and strong interpersonal skills
  • Demonstrated ability to provide effective program management excellence in terms of setting program plans for the lifecycle of a program from discovery through commercial launch

Responsibilities

  • develop, maintain and control the integrated program timelines at the program team level
  • tracking of progress (baseline vs. latest estimate) made on key activities, tasks, deliverables, milestones and stage gate decisions
  • owning of scenario planning relative to scope, time, cost impact as part of effective decision making
  • identify activities on the critical path
  • communicating the status of the program to key stakeholders
  • demonstrate creativity and resourcefulness in identifying, monitoring and mitigating risks and issues such that development programs execute according to plan
  • Building relationships with key stakeholders (program leader, functional team members and leadership) to ensure alignment of program, functional and company objectives to deliver the program strategy and promote program goals
  • Coordinating the program team’s day-to-day communications, including, facilitating cross-functional team meetings, leading discussions to drive decision-making, scenario planning, preparing agendas and meeting minutes, defining and resolving risks and issues
  • Partnering with Finance to develop and track program budgets and resource plans
  • Providing oversight of third-party vendor activities and strategies which include status of vendor deliverables and third-party vendor metrics data
  • Supporting R&D processes as they relate to vendor operational qualification/documentation and vendor performance management
  • Investing time in coaching, mentoring and acting as a role model for other program managers to enhance their skills and performance at a higher level.
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