Pfizer Clinical Project Manager (CPM), Director, Rare Diseases in Hartford, Connecticut
This is a remote based or on site role at one of the Pfizer R&D locations: La Jolla CA, Groton CT, NYC, Collegeville PA.
The Clinical Project Manager (CPM) will lead and manage the core 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 and /or all of the studies within a less complex 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.
Accountable for managing overall study timelines, budgets and quality targets
Accountable for building, forecasting and managing the Clinical Trial Budget
Leads the core study team; manages, facilitates and documents core study team meetings (e.g.meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
Ensures adequate study team resources and leads study team chartering to ensure that study team structure, including sub-teams, are effective and efficient
Fosters optimal study team health including formal team effectiveness assessments and action planning
Manages study team communications to ensure cross-functional connectivity among study team members and supporting functional lines
Leads and oversees the study risk planning process (e.g. IQMP)
Oversees operational metrics across study and manages trends and escalations
Accountable for delivery to Best In Class metrics
Acts as a single, authoritative source of the study information and leads study level status reporting per organizational norms and expectations
Ensures maintenance and accuracy of SOP log
Leads awareness and resolution of SQEs and escalations
Leads the study work order and change order processes
Ensures comprehensive operational input to protocol design
Monitors and remediates quality metrics and completes remediation tracker
Responsible for inspection readiness
Ensures Quality Gate timing planning, and team 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 study(ies) in part or in full to technical and executive governance.
If taking on 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 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
BS - minimum of 10 years relevant experience
MS/PhD - minimum of 7 years relevant experience
Experience in operationalizing clinical trials in Rare Disease
Recent experience working with Rare Disease KOLs at academic centers
Prior Pfizer 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
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 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 todiscuss with higher level management
Strong interpersonal skills
A career at Pfizer offers opportunity, ownership and impact.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.