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Clinical Trial Diversity Lead

Employer
Pfizer
Location
Remote, Remote, United States;
Salary
Competitive
Closing date
Dec 4, 2022

View more

Discipline
Health Sciences, Medicine
Position Type
Full Time
Organization Type
Pharma
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JOB SUMMARY:

Pfizer is committed to reducing health disparities through our clinical trials and ensuring that our clinical study populations and our resulting regulatory dossiers fully represent the racial and ethnic diversity of the countries where we conduct our clinical trials, and the epidemiology of the diseases we intend to treat or prevent.

The Clinical Trial Diversity Operations Lead will be a key member of the Clinical Trial Diversity Center of Excellence team and will be specifically responsible for:
  • Coordinating and implementing strategies for specific interventional clinical trials that allow for the recruitment and retention of diverse and representative populations in collaboration key internal stakeholders.
  • Partnering with Clinical Teams and Global Medical Epidemiology to define diversity goals, design study level strategies to meet those targets and adjust and implement these strategies throughout execution of the trial.
  • Maintaining diversity expertise across the clinical, regulatory, and development domains and support Participate Recruitment Leadership Team and the Head of Clinical Trial Diversity CoE on special projects and steward global initiatives to improve operational efficiencies.
  • This individual should be able to work independently with minimal supervision


JOB RESPONSIBILITIES:
  • Support the clinical study teams through the entire planning phase of the study.
  • Support clinical in the creation of governance planning documents, in support of diversity, Clinical Development Plan, Clinical Protocol Template and Operations Implementation Plan.
  • Partner with Global Medical Epidemiology to establish scientifically sound diversity goals for each disease we support, across Race, Ethnicity, Age and Sex.
  • Collaborate with the Participate Recruitment Strategists, providing diverse insights into the Participate Profile, including considerations for recruitment and retention of diverse participates.
  • Partner with Trial Feasibility and Site Selection colleagues to help influence downstream decision making that could impact diverse patient recruitment/retention (i.e., Site Selection).
  • Review and assess Preliminary Investigator Site List to ensure a study is powered to reach diverse recruitment goals. Provide guidance and highlight diversity focused sites that will require a higher level of support.
  • Work closely with Site Relationship Partners to support and elevate site level discussions on diversity.
  • Collaborate within the Participate Recruitment and Clinical Trial Experience Team Patient Recruitment Strategists' and to help influence downstream decision making that could impact diverse patient recruitment/retention.
  • Implement a Study and Site Level diversity strategy, that takes into consideration the epidemiology of the disease, and considerations for site selection and site support within the US.
  • Create diversity focused training materials to be used during an Investigator Meeting or Site Initiation Visit.
  • During the recruitment phase of a study, monitor the diversity dashboard for assigned studies and identify early trends or potential issues in diverse patient recruitment, at a study and site level.
  • Support the creation of study level Diversity Plans with Global Regulatory Affairs, in alignment with FDA's guidance on submissions
  • Attend and Lead monthly Clinical Trial Diversity Center of Excellence meeting, and contribute to meeting agenda topics, completion of meeting minutes and follow up actions.
  • Support clinical trial diversity monthly metrics creation for GPD senior leaders.
  • Support additional diversity initiatives as needed.
  • Operates effectively in a highly matrixed environment.
  • Responsible for supporting multiple studies concurrently.


QUALIFICATIONS & SKILLS:

In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:
  • BS/Equivalent with 10 years' experience
  • At least 4-6 years of leading complex cross functional teams with success
  • A broad-based experience in clinical research, including clinical trial conduct, knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
  • Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
  • Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict


PREFERRED QUALIFICATIONS
  • Master's degree (MA/MBA/MS) and 8+ years of experience.
  • Doctorate (PhD/PharmD/JD) and 9+ years of experience.
  • Advanced degree in Public Health
  • Previous engagement with the Clinical Trial Diversity Center of Excellence
  • Bilingual in English and Spanish


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.
Work Location Assignment:Flexible

Eligible for Employee Referral Bonus: YES

#LI-PFE

#LI-Remote

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Relocation assistance may be available based on business needs and/or eligibility.

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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Medical
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