Clinical Project Manager - Oncology ( Director )

Salary depends on experience
Posted on 02/22/18
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 02/22/18

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. 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.

CPM at Director level will be accountable for developing the operational strategy and managing the timelines, budgets and quality of large or complex studies or a small /moderately sized program. This includes understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy). It may also include planning and oversight of strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.

May be required to provide supervision to other CPMs within a program.

Cross-functional team leadership of clinical trial delivery:

  • Single point of accountability for delivery from vendor selection through CSR/submission
  • Accountable for managing overall study timelines, budgets and quality targets for an individual protocol / program
  • 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 of clinical trial from study concept in development planning to submission/defense
  • Provides operational strategy for program/protocol development
  • Provides high quality study information to support timely decision making
  • Accountable for building,forecasting and managing the ClinicalTrialBudgetfor the program

    Drive operational delivery at the study level and across studies:

  • Establish and charter the study team
  • Lead the study team in achieving goals & milestones manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs)
  • 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 study/ program plan
  • Manage critical changes and/or variance infinancial forecast,schedulescope and deliverables

    Leads the study team to manage risk mitigation strategies including:

  • Identifying study 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 maintainingInspectionReadiness documents according to GSOP requirements (maintaining Study Team Roster, Vendor List, Systems List, Decision Log, SOP Log)

    May perform some program level work in addition to study level work, some additional responsibilities may 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 theoperationally-focused co-development teams with anotherdevelopment partner(s), where applicable

    Training and Education:

  • 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

Qualifications:

  • BS – minimum of 10 years relevant experience
  • MS/PhD – minimum of 8years relevant experience

Prior Experience:

  • 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 tobudget

    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 working at the program level in addition to the study level, additional capabilities & skills required include:

  • Broad drug developmentexperience
    • Understands interplay/intricacies of drug development program
    • Understands how studies fit together and planning involved (sees the big picture)
  • Broad project managementexperience
  • 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

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