Director, Project Management in San Diego, CA

$200K - $250K(Ladders Estimates)

ACADIA Pharmaceuticals   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 37 days ago

The Project Manager (PM) is the operational leader for the global development program/early development projects and provides project management support to the Development Team/Early Development Team. The PM is responsible for management and delivery of the integrated development plan, encompassing the strategy for the medicine across indications and ensuring alignment across strategic/operational/tactical plans, in support of the overall objectives and priorities of the program. Responsible for project management of Regulatory submission deliverables such as INDs and amendments, CTAs and amendments, sNDAS, NDAs and amendments/supplements, MA and management of marketed products/indications Lifecycle Management programs.

Primary Duties & Responsibilities:

  • Drives development of project level goals that contribute to the overall goals of R&D and drives execution of the project in a manner that achieves delivery of the goals/objectives and the agreed plan without compromising project deliverables or relationships.
  • Leads and facilitates data needed for decision analysis with the team including development and assessment of outcome scenarios and alternative development options, robust go/no go decision criteria, probability of technical and regulatory success, value and investment implications.
  • Consistently assesses program and project-level strategy relative to the overall R&D portfolio prioritization to ensure an appropriate balance between project priority and resource consumption. Proactively recommends and drives the operational plan and resource adjustments to improve productivity and return for the program.
  • Drives development of the project-level goals that contribute to the overall objectives for the R&D portfolio. Monitors and reports to executive management on progress of the program goals.
  • Drives milestone decision-point planning and associated deliverables across functions to achieve the overall program objectives. Clearly defines the critical path and generates clear decision criteria for the project.
  • Prepares and manages governance interactions in partnership with the Clinical and/or Commercial lead.
  • Develops project-level budgets and resource plans on behalf of the team. Proactively manages the overall project budget and resource demand including potential business development projects. Ensures that cross-functional efficiencies are identified and maximized
  • Manages an integrated project budget and resource plan in partnership with the Team Lead, Finance team member and functional line representatives on the team.
  • Leads governance within R&D for assigned projects
  • Leads the identification of operational and project/program issues for discussion with appropriate team leadership. Drives resolution across the team through options assessment, effectively documenting decisions and rationale. Identifies team performance issues and partners with the clinical leader to recommend and develop appropriate action.

Education/Experience/Skills:

Bachelor's degree in life sciences. PMP highly desirable. Equivalent combination of relevant education and applicable job experience may be considered. Minimum 10 years of progressively responsible, relevant experience focusing on project management with 4 years in a leadership role which includes experience managing cross-functional project teams.

Must possess:

  • A strong understanding of the clinical development process and the principles, concepts, practices, and standards of pharmaceutical project management.
  • Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality and risk management to teams.
  • A strong understanding of the clinical development process and the principles, concepts, practices, and standards of pharmaceutical project management.
  • Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GXPs governing the conduct of clinical trials is required.
  • Extensive pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and regulatory interactions.
  • CNS experience required.
  • Excellent interpersonal, organizational, written and verbal communication skills.
  • Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail.
  • In-depth knowledge and skill with Microsoft Project, Microsoft Word, Microsoft Excel, and other reporting and tracking tools.
  • Ability to work under limited supervision, determine personal work plan, and schedule tasks and activities accordingly.
  • Ability to accommodate shifting priorities, demands and timelines.
  • Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.
  • Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team's ability to achieve goals and meet timelines/deliverables.
  • Late-stage drug development experience preferred.
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.
  • Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.


Valid Through: 2019-10-8