Pfizer

Senior Director of Study Management

Employer
Pfizer
Location
Remote, New York
Salary
Competitive
Posted
May 02 2021
Ref
4807799
Position Type
Full Time
Organization Type
Pharma
JOB SUMMARY

The Senior Director/Supervisor of Study Management will provide strategic TA and program level contributions such as input to development plans and program-level strategies for Study Management. They will be accountable for delivering a portfolio of assets or compounds. They will provide managerial oversight to study management colleagues in their respective groups and their associated deliverables within and across that portfolio. The Senior Director/Supervisor of Study Management is responsible for the talent development of colleagues and preparing Study Managers to deliver on studies.

They are accountable to ensure all of their direct reports are appropriately trained. They are accountable to ensure study managers are following Pfizer SOPs and providing leadership and
appropriate oversight to the CROs. They are accountable to ensure that Study Managers are delivering according to agreed plans and to ensure appropriate proactive escalation of risks and deviations to plans and that any asset level strategies are appropriately implemented.

The Senior Director/Supervisor of Study Management will define and leverage Operational Metrics, Study Plan variance and trend reports to drive the business and support the oversight and management of both the study managers and CROs. They will also interface with CRO managers to resolve issues and escalate resource concerns.

The Senior Director/Supervisor of Study Management is a Subject Matter Expert (SME) on study management processes and works with their Study Management Group Lead to facilitate the sharing of therapeutic/functional area expertise and best practices within their group and where applicable across the Study Management organization. They may sponsor, lead or represent Study Management on cross-functional cross-departmental or enterprise level work streams that influence senior management and have an impact on business direction.

The Senior Director/Supervisor of Study Management will interface as needed with various stakeholders across the organization including but not limited to Operational Group Leads, TA Clinicians and GCLs, RU leaders, Data Management Group Leads, TA Heads/DCSMs to ensure appropriate issue resolution/escalation and healthy stakeholder relationships. They will also interface with the study management and monitoring functions at the Contract Research Organizations (CROs) to ensure optimization of services.

They are accountable for building and ensuring Therapy/Functional Area expertise and technical Study Management expertise for their group of direct reports through recruitment and talent
development/management of staff and the development of training strategies to enhance study management

JOB RESPONSIBILITIES

Line Management and Strategic Implementation
  • Partners with Study Management Group Lead on defining & providing managerial leadership of strategies within group and specific implementation of processes, quality goals and standards
  • Line management of Study Managers including Director level Study Managers who have accountability for large priority studies
  • Actively develops talent through providing focused career development, performance management & manages retention
  • Responsible for the development and adherence to consistent harmonized processes and high quality clinical trial deliverables for clinical projects
  • Create, maintain and assume accountability for a culture of high quality and customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines
  • Support and continuously evaluate and evolve the Study Manager role to add value and efficiencies to internal study management
  • Works with other cross functional lines to improve processes and important quality aspects of studies including site selection, recruitment and retention practices, Significant Quality Event (SQE) process, etc. to simplify processes and ensure quality in the studies
  • Responsible to ensure Study Management elements are considered as part of the whole of the Operational Strategy across as asset/program by working with Operational Leads, Global Clinical Leads and Asset Leads as needed.


Study Management Sourcing and Oversight
  • Works with sourcing partner/ resourcing lead to ensure provision of technically trained Study Managers per sourcing strategy
  • The SDSM will interface with Ops Leads/ CPM Group Leads and CPMs as applicable for issue escalation, SM performance issues and to discuss resource demand and for specific study resource requests.
  • Contributes to the Study Startup, Study Monitoring & protocol recruitment plans of linked studies within an asset/program
  • Inputs and reviews SMPs within Asset assignment to ensure consistency and excellence
  • Supports study/program level submission readiness


Study Team and other Interfaces
  • Subject Matter Expertise
  • In strong collaboration with other colleagues or functions (peers, project leads, and group leads):
  • Leads cross departmental initiatives
  • Implements strategies to ensure consistent processes
  • Leads and/or participates in specific process improvement initiatives; monitors and reports on implementation progress as appropriate
  • They will be the experts on the study management related SOPs. They are expected to serve as a Study Management SMEs on BPIs and SOP development/update projects. They should proactively share best practices across CD&O.


TECHNICAL COMPETENCIES
  • Ability to understand and assimilate high-level data and operational metrics and trends
  • Strategic thinking and targeted problem solving skills
  • Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers
  • Strong interpersonal skills
  • Establishes strong relationships with customers, strives to understand and meet customer requirements
  • Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
  • Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures; motivates through example, commitment, loyalty and enthusiasm
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
  • Creativity and/or ability to put innovative approaches into practice in clinical development


QUALIFICATIONS / SKILLS

Training and Education:
  • Extensive global clinical trial/study management experience.
  • Working knowledge of GCPs, monitoring, clinical and regulatory operations.
  • BS - minimum of 12 years relevant experience.
  • MS/PhD - minimum of 8 years relevant experience.


Prior Experience Preferred:
  • Experience in the management and direct supervision of internal resource required.
  • Demonstrated effectiveness working in a multidisciplinary, matrix team environment required.
  • Direct study management expertise required.
  • Experience of resource management (staff and financial) is required.
  • Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend.
  • Evidence of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials is preferred.
  • Experience in therapeutic / functional area of expertise desirable.
  • Evidence of strong leadership, influencing, negotiation, and management skills is preferred.


Skills:
  • Understands how to work with vendors to accomplish tasks.
  • Ability to interpret study level data & translate and identify risks.
  • Ability to proactively identify & mitigate risks around site level in study execution.
  • Understands feasibility of protocol implementation.
  • Country level cultural awareness and strong interpersonal skills.
  • Keen problem solving skills.
  • Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management).
  • Excellent communication skills, both written and verbal Must be fluent in English.
  • Managing through a Service Provider.


Other Job Details:
  • Eligible for Employee Referral Bonus: YES
  • This is a remote position


Sunshine Act

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.

EEO & Employment Eligibility

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.

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