Submission Clinical Project Manager (Director)
Groton , Connecticut
November 16, 2016

About the company
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All over the world, the company 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. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
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.

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).

• 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 applicable

If 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 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 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 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 to discuss with higher level management
• Strong interpersonal skills

If expected to supervise others, additional capabilities and skills required include:
• Demonstrated ability to manage and develop colleagues

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.

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