Clinical Project Manager (Senior Director) - Oncology - La Jolla, CA | Biospace
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Clinical Project Manager (Senior Director) - Oncology

Pfizer Inc.

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Location:
La Jolla, CA
Posted Date:
8/24/2017
Position Type:
Full time
Job Code:
1610068
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Clinical Project Manager (CPM) will lead and manage the cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense for a program. The CPM is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPM will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets. The CPM is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health for a program.

CPM at Senior Director level will be accountable for developing the operational strategy and delivery of a complex and large programs or portfolio of programs. This includes managing the timelines, budgets, and quality across all studies in the program or portfolio, understanding and planning how the interdependencies across different studies in a program fit together (e.g. how the readout from a study informs the next steps and overall program strategy). Where applicable, it will also include planning and oversight of strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category. Senior Director CPMs will play a pivotal role in building scenarios for budget and timeline, as well as identifying operational risks to delivery, prior to funding decisions from governance.

CPM at Senior Director level will provide supervision to other CPMs if required, and will coordinate the work of other CPMs working within the program/portfolio.Cross-functional team leadership of large/complex clinical trial(s), multi-study program(s) or portfolio of programs:

  • Single point of accountability for delivery from vendor selection through CSR/submission
  • Accountable for managing overall timelines, budgets and quality targets
  • Ability to lead and manage in an ambiguous, dynamic environment
  • Responsible for cross-functional team communication and effectiveness
  • Develop and maintain positive team dynamics and health
  • Disciplined project and risk management approach
  • Overall operational responsibility from study(ies) concept in development planning to submission/defense
  • Provides operational strategy for program/protocol development
  • Provides high quality program/portfolio information to support timely decision making
  • Accountable for building, forecasting and managing the Clinical Trial Budget for the program

Drive operational delivery of the large/complex clinical trial(s), multi-study program(s) or portfolio of programs:

  • Accountable for delivery to improved cycle times metrics
  • Facilitate effective decision making
  • Lead the team in managing issues and problem solving
  • Demonstrate Leader Behaviors in motivating and supporting the study team
  • Ensures execution against plan
  • Manage critical changes and/or variance in financial forecast, schedule scope and deliverables
  • If directly responsible for large/complex trials, establish and charter the study team. Lead the study team in achieving goals & milestones manages, facilitates and documents core study team (e.g. meeting agendas & minutes, action logs and decision logs)

Leads large/complex clinical trial(s), multi-study program(s) or portfolio of programs to manage risk mitigation strategies including:

  • Identifying study (where applicable), program or portfolio level opportunities and risks
  • Preparing, maintaining and implementing risk mitigation and contingency plans
  • Ensures progression of SQEs and resolutions
  • Ensures cross-functional awareness, buy-in and agreement to risk/opportunities, action plans and resolution
  • Ensures all key stakeholders / senior management are informed of study/program level major risks/opportunities and corresponding contingency /mitigation plans.
  • Ensures communication and integration of study level risks/opportunities at the program level
  • Responsible for coordinating, managing and maintaining Inspection Readiness documents according to GSOP requirements (maintaining Study Team Roster, Vendor List, Systems List, Decision Log, SOP Log)

Additional responsibilities include:

  • Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs
  • Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter
  • Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities
  • Establish and ensure adherence to operational standards and best practices for the asset or program
  • Lead the Operations Strategy including the Clinical Operations Plan along with the Sourcing/Vendor Strategy
  • Manage and deliver to timelines, budget and quality for all studies in a program
  • Interface with the GCL and program level roles including at the CRO
  • Participate in program level feasibility & country strategy
  • Attend and represent Clinical Operations at governance meetings (including co-development studies)
  • Manage & support escalations
  • Develop and lead execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, rapid response. Manage other submissions activities as necessary
  • Support planning and technical review of licensing opportunities and/or due diligence activities. Oversee strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.
  • Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program
  • Communicate opportunities and risks to the category leadership. Ensures cross functional buy-in to risk mitigation plans and asset team's proposals for governance endorsement appropriately capture operational inputs and risks
  • Define and execute operational transition from early to late phase development and for the in-licensing and acquisition opportunities
  • Represent CD&O on the operationally-focused co-development teams with another development partner(s), where applicable
  • Coordinate the work of other CPMs working within the program/portfolio and if required will also provide supervision

When supervisory responsibilities are assigned:

  • Provide effective line management and oversight
  • Responsible for the identification, selection, development, performance management, mentoring/training, retention and engagement of CPMs
  • Accountable to ensure their direct reports possesses appropriate team leadership functional and technical skills to enable successful leadership of the study teams
  • Holds regular coaching and feedback sessions of CPMs within group and maintains a diverse, high-performing team.

    Requirements

    Training and Education Preferred:

    • Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of GCPs, monitoring, clinical and regulatory operations
    • BS - minimum of 15 years relevant experience
    • MS/PhD - minimum of 10 years relevant experience

    Prior Experience Preferred:

    • Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
    • Demonstrated project management / leadership experience
    • Experience in understanding of key drivers impacting budgets
    • Experience in building a CTB and managing project to budget

    Skills:

    • Ability to lead cross-functional teams, identify, resolve & escalate issues
    • Ability to represent & communicate clearly at Governances
    • Ability to understand and assimilate high-level data from all functions
    • If expected to supervise other CPMs, demonstrated ability to manage and develop colleagues.

    Additional capabilities & skills required include:

    • Broad drug development experience
    • Understands interplay/intricacies of drug development program
    • Understands how studies fit together and planning involved (sees the big picture)
    • Broad project management experience
    • Strategic thinking and targeted problem solving skills
    • Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level management
    • Strong interpersonal skills

    Additional Details:

    • Eligible for Employee Referral Bonus
    • Can be remote / regionally based.
    • Grade 18

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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