Pfizer

Director, Clinical Scientist

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
November 25 2021
Ref
4828463
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

The clinical scientist lead is a clinician who will provide medical and scientific program support for a global clinical scientist team on a program, ensuring consistency of approach and strategy and appropriate oversight of clinical scientist activities within a program or provide medical and scientific support for multiple, global, Phase 1-4 clinical studies.

The clinical scientist lead is responsible for clinical scientist project management support on a program level and/or responsible for studies with a high degree of complexity, in emerging regions of the world, or large studies. They are responsible for working collaboratively with the clinical lead physician and lead study clinician physicians and may develop clinical development plans and study strategies in support of the plans.

The clinical scientist support includes multiple tasks within the categories of 1) program, protocol, and study design and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.

ROLE RESPONSIBILITIES

Performs clinical scientist activities or oversees all clinical scientist activities for a clinical program including:
  • Protocol and study design and training.
  • Data review and interpretation.
  • Study and/or program scientific and integrity oversight.
  • Safety review and communication in collaboration with safety risk leads.
  • Regulatory document, study report, and publication review and preparation.
  • Clinical study implementation oversight.
  • Ensures consistency, quality, data integrity, safety, and alignment with company values in all clinical scientist activities.


Represents clinical scientist program-wide functions on Clinical Project Team, Clinical Scientist Leadership, Clinical Program Team, Clinical Study Teams, Asset Operational meetings, Asset Program Teams, and Regulatory Strategy teams. May manage and lead Clinical Project Team meetings. Ensures individual contributor clinical scientists are aligned and consistent in their approach to process and strategy interpretation across all studies within a program. Contributes to discussions to ensure consistency across all programs.

May provide line management support for other clinical scientists within the program. Reviews work, develops staff, ensures appropriate succession planning, and provides ongoing feedback. Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).

Using expert knowledge of vaccine clinical trials, provides oversight of operational strategic partner involvement at a program or study level and in collaboration with lead study clinicians and clinical lead. Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with clinical lead, lead clinician, Development Operations program lead and Alliance Partner representatives.

Provides clinical scientist leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits. In collaboration with the clinical lead, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, Key Opinion Leaders and potentially regulatory meetings.

Represents Vaccine Clinical Research (VCR) and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues. Leads change for VCR on new company initiatives.

Influences management/senior staff decisions and is viewed as the subject matter expert on clinical scientist decisions impacting a program and potentially the clinical research unit.

Collaborates with clinical program lead and other team members on development of program strategy and Clinical Development Plan for a program or multiple programs.

QUALIFICATIONS

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.

Must Have
  • BA/BS science or health-related field
  • Minimum 8 years' experience in Clinical Research including a working understanding of clinical protocol development and other required documents (e.g. Informed Consent)
  • Expert working knowledge of Clinical Data Review including query generation and management
  • Expert working knowledge of the clinical research process and Good Clinical Practices
  • Strong written and oral communication and cross-functional collaborative skills
  • Strong ability to work independently
  • Proficiency with Word, PowerPoint, and Excel


Nice To Have
  • MS or PhD in science or health-related field
  • Experience with managing colleagues, either direct reports or matrix management
  • Working knowledge of vaccine therapeutic area
  • Demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
  • Independently authored clinical protocols and other clinical study documents
  • Experience with participating in and informally leading an operational team
  • Applies knowledge of internal/external business challenges to facilitate process improvements
  • Strong knowledge of statistics, data analysis, and data interpretation
  • Has significant experience working independently and collaborating with multiple functional groups within and outside the business line
  • Has demonstrated an advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives


OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

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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