Pfizer

Senior Director/Supervisor of Study Management

Employer
Pfizer
Location
Remote, Colorado
Salary
Competitive
Posted
May 02 2021
Ref
4812593
Position Type
Full Time
Organization Type
Pharma
The Senior Director of Study Managementwill provide strategic Therapeutic Area (TA) and program levelcontributions 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 of Study Management is responsible for talent development of colleagues, preparing Study Managers to deliver on studies. They are accountable to ensureallassigned direct reports are appropriately trained. They are accountable to ensure Study Managers are following Pfizer Standard Operating Procedures (SOPs) and providing leadership and appropriate oversight to the Contract Research Organizations (CROs).

They are accountable to ensure that Study Managers are delivering according to agreed plans and to ensure appropriate proactive escalationofrisksand deviations to plans, and that any asset level strategies are appropriately implemented.

The Senior DirectorofStudyManagementwill define and leverage performance data, e.g. 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 of Study Management is a Subject Matter Expert (SME) on study management processes and works with their Study Management Group Lead (SMGL) to facilitate the sharing of therapeutic/functional area expertiseandbestpractices 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 of Study Management will have responsibility for the oversight and delivery of complex and/or high priority assets with multiple indications and/or studies. They willinterface as neededwithsenior stakeholders across the organization including but not limited toClinical Operations Heads, Clinical Group Leads, BU and RU leaders,Data Management Group Leads, Area Heads/DCSOstoensureappropriateissue resolution/escalation and healthy stakeholder relationships. They will also interface with the senior stakeholders within study management and monitoring functions at the CROs to ensure optimization of services. The Senior Director of Study Management will interface with senior leadership within pCROs to drive progress across their assigned assets, and will influence strategic direction for this partnership within their therapy area. They will work with COHs and TA category heads to influence interactions with external Agencies as required. The Senior Director of Study Management may be delegated Study Management Group Lead responsibilities as required.

Theyareaccountableforbuildingandensuringtherapy/functionalareaexpertise

andtechnical studymanagementexpertisefor their group of direct reports through recruitment and talent development/management of staff and the development of training strategies to enhance study management.

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 ManagersincludingDirectorlevel Study Managers who have accountability forlarge priority studies
  • Actively developsand retainstalent through providing focused career development, performance management, and an inclusive culture
  • Responsible for the development and adherence to consistent harmonized processes andhigh-qualityclinical 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
  • Workwithothercrossfunctionallinestoimproveprocessesandimportantqualityaspectsofstudiesincludingsiteselection,recruitmentandretentionpractices,SignificantQualityEvent(SQE)process,etc.tosimplifyprocessesandensurequalityinthestudies
  • 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,Clinical Study Group 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 the Clinical Operations Leads / Clinical Study Group Leads and CSTLs as applicablefor 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
  • StudyTeam andother 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
  • Provides expertise on the study management related SOPs and serves as a Study Management SME on BPIs and SOP development/update projects. Proactively shares best practices across CD&O.


BASIC QUALIFICATIONS

Training and Education
  • Extensive global clinical trial/studymanagementexperience
  • Working knowledge of GCPs, monitoring, clinical and regulatory operations
  • BS - minimum of12yearsrelevant experience
  • MS/PhD - minimum of 8 years relevant experience


Prior Experience
  • Experience in the management and direct supervision of internal resource
  • Demonstrated effectiveness working in a multidisciplinary, matrix team environment
  • Direct study management expertise
  • Experience of resource management (staff and financial)


  • Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
  • Evidence of Clinical Development and pharmaceutical study execution experience


Skills
  • Ability to understand and assimilate high-level data and operational metrics and trends
  • Strategic thinking and targetedproblem-solvingskills
  • Maintainsscientific/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

PREFERRED QUALIFICATIONS
  • Thorough understanding of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials
  • Experience in therapeutic / functional area of expertise
  • Evidence of strong leadership, influencing, negotiation, and management skills
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NA

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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