Pfizer Submission Clinical Project Manager (Director) in Groton, Connecticut
This role can be remote based or at one of our Pfizer R&D locations:
Groton CT, NYC, Collegeville PA, La Jolla CA.
CPM at Director level will be accountable for developing the operational strategy and managing the timelines, budgets and quality of large or complex studies and /or all of the studies within a complex/multi-study program or multiple less complex programs. This may include 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. This includes strategy for delivering the CD&O components of submissions.
May be required to provide supervision to other CPMs within a program(s).
- Demonstrated ability to manage and develop colleagues
The Clinical Project Manager (CPM) will lead and manage the core cross functional study team (or submission sub-teams) and is the single point of accountability for the operational delivery of the CD&O deliverables for a submission. 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 CD&O submission deliverables and leading the execution of these submission teams according to time, cost and quality targets. The CPM is responsible for proactive operational risk management for their clinical study(ies) or sub-teams. This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the team(s) and ensuring optimal team(s) health.
Leads cross functional Block 2/5 submission sub- teams with accountability for delivery and an overall operational strategy
Accountable for managing overall submission CD&O sub-team timelines, budgets and quality targets
Accountable for building, forecasting and managing the CD&O submission budget
Leads the submission sub-teams (blocks 2 & 5); manages, facilitates and documents team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
Ensures adequate CD&O submission sub- team resources and leads team chartering to ensure that sub team structure, are effective and efficient
Fosters optimal team health including formal team effectiveness assessments and action planning
Manages CD&O submission sub-team communications to ensure cross-functional connectivity among team members and supporting functional lines
Leads and oversees the submission sub-team risk planning process
Oversees operational metrics across submission sub-teamsand manages trends and escalations
Accountable for delivery to Best In Class metrics
Acts as a single, authoritative source of the block 2 & 5 information and leads CD&O submission level status reporting per organizational norms and expectations
Leads the submission work order and change order processes
Ensures comprehensive operational input to submission plan
Monitors and remediates quality metrics and completes
Accountable for inspection readiness
Responsible for obtaining requisite operational governance approvals per organizational norms and expectations. Leads preparations and presents the study to operational governance
Provides clinical timelines, cost, and operational risk sections of the governance presentations, memos, and other materials used for decision making. Participate and may present assigned submissions(ies) in part or in full to technical and executive governance.
Program level work in addition to study level work, 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
Inspection management & readiness
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 applicableIf applicable, functional management responsibilities include:Develop others, including recruitment and retention, career development, performance management and succession planning
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
BS - minimum of 13 years relevant experience
MS/PhD - minimum of 8 years relevant experiencePrior 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 to budget
Experience leading submission activities
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 functionsIf working at the program level in addition to the study level, 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
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Additional Offer Details:
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All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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