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Director of Clinical Site Operations

Employer
Pfizer
Location
Remote, District of Columbia
Salary
Competitive
Closing date
Apr 21, 2021

View more

Discipline
Health Sciences, Medicine
Position Type
Full Time
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma
ROLE SUMMARY

The Director of Clinical Site Operations (DCSO) is accountable for ensuring appropriate Site Relationship Partner/Site Relationship & Excellence Partner (as applicable), as well as Clinical Trials Manager resources are in place to deliver on study and site-level start-up activities in-line with study milestones in the designated countries/clusters/regions. The DCSO is also accountable to ensure operational site management and oversight activities within a designated country/cluster/region. This role is also accountable for the Site Excellence Partner remit within their assigned country/cluster/region and supervises the compliance oversight activities to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.

This is a strategic role that coordinates cross functionally with others in Study Start Up, Study Optimization, and Study

Management to provide input to country and site selection and to execute investigator site strategies and site-level start-up activities.

The Director of Clinical Site Operations represents Global Product Development (GPD) as the in-country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across a portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy. This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders. Applicable to certain countries/countries/regions, the role also is accountable for therapeutic area/asset/study-level activities, working in coordination with other key GPD roles, including but not limited to, Directors of Study Management and Clinical Study Team Leaders.

The Director of Clinical Site Operations leads initiatives that support the clinical development environment within their country/cluster/region to facilitate Pfizer's clinical development goals and scientific leadership. For example, this role actively manages threats to, or identifies opportunities for, clinical trial conduct through engagement with local clinical development leaders, institutions/networks, and/or regulatory authorities.

The Director of Clinical Site Operations provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the study and site level) on the trial's conduct.

The Director of Clinical Site Operations will contribute to and implement strategic initiatives as a representative of the GSSO Leadership.

Management of Site Relationship Partner, Site Excellence Partner, Line Manager of Clinical Operations and Clinical Trials Manager
  • Lead and coach allocated resources within assigned country/cluster/region.
  • Oversee job function as described in the Site Relationship Partner, Site Relationship and Excellence Partner, Site Excellence Partner, line manager of clinical operations and Clinical Trials Manager job description and ensure compliance with training requirements.
  • Where required, perform joint site visits with direct reports to assess performance.
  • Manage country/cluster/regional budget in accordance with financial expectations.
  • Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and solid investigator site relationships.
  • Establish consistent direction and priorities across assigned countries/cluster/region.


Country/Cluster/Regional Environment & Across Site/Study Management:
  • Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes. Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
  • Responsible for the oversight of the operational delivery including the monitoring activities as performed by partner CROs, safety and quality of sites in the country/cluster/region.
  • Demonstrate Therapy Area expertise, where appropriate.
  • Responsible for timely and quality site start-up including activation.
  • Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient safety in selected investigational sites.
  • Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable.
  • Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed.
  • Collaborate with local contract organizations (e.g., CRO) as needed to ensure overall delivery, quality, local regulatory and GCP compliance.
  • Working within the directions of a global strategy, build portfolio-aligned, investigational sites/network relationships and participate in local industry forums to shape performance of ethical clinical research, as needed.
  • Shape local clinical research environment by promoting GCP, ethics, regulatory process and investigator training.
  • When required, contribute to area or global GSSO strategy by leading and participating in area or global initiatives.


Relationship Management
  • As applicable, act as the GPD representative on Country Medical Councils to ensure transparent communication within relevant Pfizer stakeholders in the cluster/country.
  • Ensure a proactive relationship is maintained between GSSO colleagues and other in-country functional lines such as regulatory, safety and medical affairs
  • Proactively manage the relationship with other functional lines within GSSO e.g study start-up, study optimization and study management to drive successful portfolio delivery in-country.
  • Proactively manage the country relationship with local external stakeholders (e.g., investigators, regulators, ethics committees, pharma associations, etc.).
  • Develop relationships with the CROs/vendors locally in support of delivery of GSSO strategies.


  • Extensive knowledge (minimum 14 years) of clinical trial methodologies with proven ability to deliver high quality clinical trial conduct obtained while working with a multi-national pharmaceutical company and/or clinical research organization.
  • Must be fluent in English. Local language capabilities are an advantage in this role.
  • In general, candidates for this job would hold the following levels of education/ experience:
  • BS/BSc/MS/MSc or equivalent and extensive clinical research experience
  • PhD/MD or equivalent and extensive clinical research experience

Skills
  • People management experience
  • Ability to lead and manage diverse teams.
  • Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities.
  • Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO.
  • Demonstrated understanding of HR procedure and policies at global and local level.
  • Demonstrated ability to engage with senior stakeholders internally and externally to the organization.
  • Ability to work effectively with line support functions including finance, HR across the region.
  • Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed.
  • Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies.
  • Availability to travel within the region and/or globally as required.


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.

Other Job Details:

Last Date to Apply for Job: April 23rd, 2021

Eligible for Employee Referral Bonus: YES

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Sunshine Act

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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.

Medical

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