Director - R&D Project Management

Pfizer   •  

Fresno, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 43 days ago

  • The Director R&D Project Manager (AssetProject Manager) provides comprehensive project management for Pfizer asset teams to ensure alignment and execution of research, development, medical, and commercial strategic and operational objectives. The Asset PM serves as the program operational leader ensuring all cross functional deliverables are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The Asset PM’s responsibilities encompass asset strategic and scenario planning, program and submission execution, team effectiveness, resource management, risk management, and information and communication management. The Asset PM needs to have comprehensive understanding of the governance process, strategic and tactical planning, and the foundational tools that support planning, communication, and continuous improvements in the area of operational delivery.

Asset Program Development, Strategy, and Planning

  • Working with Asset Team leadership, leads development of integrated program plans (e.g., Development, Lifecycle, and Operating plans) and ensures alignment with the overall candidate strategic plan and operational and Partner Line plans for the program scope, which may span from Lead Development to Loss of Exclusivity.
  • Drives decision point planning and the associated deliverables across all functions of the team and contributes to the strategic planning process for the project.
  • Offers leadership in asset-level planning, including development and assessment of scenarios and options, robust decision criteria, risk management, and internal/external communication and stakeholder management strategies.
  • In partnership with the Asset Team Leader, Finance Lead, and Partner Line representatives, accountable for developing and maintaining an integrated program level budget and accurate updated annual forecasts.
  • Designs, recommends, and implements new processes, approaches, or tools to manage the program or team.
  • Provides timeline and budget inputs for asset valuation.

Project Planning

  • Drives creation/maintenance of asset-level integrated development plans in partnership with the Asset Team Leader, recognizing and driving delivery of key interdependencies across functional lines.
  • Leads development of the program critical path, decision criteria, and milestones/stage gates.
  • Ensures all lines understand asset strategy, key milestones and interdependencies.
  • Leads the oversight of the program level plan (schedule) in collaboration with the Project Planner and proactively identifies and manages opportunities to optimize delivery of the asset-level plan.
  • Partners with the Project Planner to ensure that project schedule, resource management, and project controls are established and maintained.
  • Facilitates scenario planning including the development and assessment of options.

Project Execution and Delivery

  • Provides cross-functional operational leadership to the team.
  • Leads the development and coordination of program level goals in partnership with the Asset Team Leader and closely monitors progress against these goals for operational efficiency ensuring the program delivers on time, within scope, and on budget.
  • Monitors activities across all team members and line functions involved in the program to ensure achievement of key decision points and milestones according to time, cost, and quality parameters of the endorsed plan. Influences leadership across functional lines to ensure efficient delivery of projects.
  • Proactively identifies and manages emerging changes and opportunities; drives iterations of the plans collaboratively with the Project Planner to make updates in the project schedule; works with the team to optimize resource utilization and maximize return on investment.
  • Reviews and/or approves operational activities and costs; monitors and manages program activities against the approved budget; leads the team to manage exposures through internal tradeoffs or seek approval through appropriate processes for additional budget as necessary.
  • Negotiates the allocation of Partner Line resources to support the endorsed strategy and development plan.
  • Facilitates the identification of operation and project/program issues and risks and drives resolution through a matrix environment, effectively documenting decisions/rationale.
  • Partners with the Asset Team Leader to prioritize asset level deliverables and align across functions.
  • Drives process and accountabilities matrix for key cross functional deliverables.
  • Drives team process for preparation of governance presentations (in some cases creating slides and/or integrating inputs to prepare the presentation).

Program Risk Analysis and Management

  • Leads the team in the preparation, implementation, maintenance, communication, and management of integrated asset risk management plans, including risk assessment and risk mitigation strategies.
  • Proactively identifies operational and program issues, facilitates development of team recommendations and action options, and ensures appropriate escalation to senior leadership and Partner Lines.
  • Partners with team and department leadership to identify options to de-risk project plans and capitalize on opportunities.
  • Facilitates team discussion and documentation of alternative development options, including pros, cons, and risks.
  • Provides assessment of timing of investment triggers and go/no go decision points.

Information and Communication Management

  • Responsible for the development and management of the communication plan for the program, including stakeholder management plan. Ensures effective, accurate, and timely communication of program information to meet the needs of the asset team and stakeholders.
  • Participates in representing the asset team in governance presentations, Operating Plan reviews, stakeholder discussions, and other venues.
  • Provides complete, accurate and timely timeline, budget and resource information in appropriate Pfizer systems to enable effective portfolio management and decision making.
  • Drives development of project level goals that contribute to the overall goals of the business and monitors progress against these goals, working in close association with the Portfolio Directors to ensure alignment. Provides project information necessary to supportportfolio-level decision making and prioritization.
  • For Proof of Concept or pivotal study readouts (and as appropriate data monitoring committees and interim analyses), coordinates internal and external communication plans.
  • Conducts lessons learned and after action reviews.

Team Effectiveness

  • Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance.
  • Understands and communicates team roles/responsibilities; helps new team members get up to speed on the project, and ensures all team members have access to project information necessary to be successful.
  • Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate.
  • Identifies team performance issues and partners with team leadership to recommend and develop appropriate actions.
  • Ensures cross-functional process efficiencies are identified and maximized in accordance with team project goals.
  • Leads team chartering process.
  • Leads implementation of team health survey.
  • Models optimal team member and meeting etiquette behaviors, encourages straight talk.
  • Clarifies project deliverables/workload to enable Partner Lines to assess resource needs, raise gaps, and partner with team leadership to resolve.

Additional Responsibilities - In some instances a PM may provide leadership in the following areas:

Alliance Programs (Co-development alliances)

  • Leads the operations for alliance projects including contributing roles on alliance sub-committees and steering committees.
  • Plays a leadership role in partnering with Finance to manage alliance budget forecasts and with PDA on asset valuation assessments.
  • Provides operational inputs (e.g., timeline and budget) for assessments of new business development/partnerships.

Submissions

  • Provides comprehensive project management for regulatory submission activities for initial market authorizations in major regions, as well as supplemental applications of significant scope.
  • Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals.
  • Provides support to the team approximately 18 months in advance of a potential submission to map out submission contents and conduct scenario analyses of cost, schedule, and resource demands to identify the most efficient plan.
  • Applies specialized knowledge of and expertise around endgame to contribute to the identification, evaluation, and optimization alternatives for the submission plan.
  • Responsible for the development of the submission integrated MS project plans and resourcing plans for endgame activities.
  • Leads the cross functional submission team.
  • Partners with the Asset Team Leader to lead advisory committee preparations.

Training & Education:

  • Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree (PhD, PharmD, MBA) desirable.
  • Mastery of project management skills and product development.
  • 10 or more years of relevant experience
  • Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable.
  • Oncology experience desirable.

Prior Experience/Skills:

  • Strong track record of performance on cross-functional teams and results through effective implementation of project management methodology, tools, and techniques.
  • Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven performance in business performance and project delivery.
  • Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
  • Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders.
  • Demonstrated ability to utilize project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis).
  • Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines (Planisware and Snapshot experience highly desirable).
  • Familiarity with clinical trial execution, working withcontract research organizations, budget management, and related areas highly desirable.
  • Track record for delivery against challenging personal and team goals.
  • Knowledge of medical and commercial issues that drive late stage development and life cycle management is desired.
  • Proven ability to succeed in a fast-paced, challenging and complex matrix team environment.

Technical Competencies:

  • Training and academic background in one of the disciplines of drug development.
    • Displays pharmaceutical business acumen including: o Knowledgeable about industry trends.
    • Familiar with the competition and with market environment.
    • Understands how asset strategies unfold in the market.
    • Able to understand and question the basic scientific assumptions underlying a drug development program/project.
    • Able to challenge and understand the implications of each discipline’s actions on others in order to reach decision points effectively.
    • Able to think strategically and operationally around the application of science and investment in drug development to optimize business benefit.
  • Knowledge of the fundamentals of Project Management and its application to drug development.
    • Able to practically apply the principles of project management process to drug development directed towards goal delivery.
    • Able to partner withinternal and external project management experts to develop and advance best practice.
  • Project Execution &Risk Management
    • Displays flexibility, problem-solving, and resourcefulness to drive path forward in ambiguous and constrained circumstances.
    • Able to interpret project data to support critical decision-making and impacts.
    • Manages project to approved timelines and budget.
    • Leads team to proactively identify and manage risks and issues.
    • Understands and can communicate the business impact of risks to the team.
    • Leverages experience to identify and drive the team to address complex risks.
  • Budget Management
    • Understands and has demonstrated ability to manage a budget; history of staying on or under budget.

Behavioral Competencies:

  • Evidence of driving team to ensure execution against plan based on time and cost criteria.
  • Demonstrated ability to translate strategy into effective operational goals and tactical plans.
  • Proven ability to develop and implement team structure and process.
  • Supports team effectiveness and delivery
  • Able to influence team through personal credibility and track record of delivery of personal and team goals.
  • Proven ability to develop a network within the company to facilitate decision making and overcome barriers to delivery.

4745610