Job Details

Submission Clinical Project Manager (Director)

Company name
Pfizer Inc

Location
New York City, NY

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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 colleaguesThe 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 planningTraining 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

Requirements

Qualifications:

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

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 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

Additional Details:

Eligible for Employee Referral Bonus

Can be remote based

Grade 15

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.

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Company info

Pfizer Inc
Website : http://www.pfizer.com

Company Profile
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

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