Manager, Study Clinician (Non-MD), Early Clinical Development - Oncology

Employer
Pfizer
Location
La Jolla, California
Posted
Dec 26, 2021
Ref
4833220
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

The overall role of the Manager, Early Clinical Development (ECD) Clinician (non-MD position) is to support the execution of one or more studies for small molecule and novel biological therapies from first in human (FIH) through proof of concept (PoC) studies, including proof of mechanism (PoM) and early signals of efficacy (ESoE) studies in a given therapeutic area.  The primary therapeutic area for this position is Oncology.

The Manager, ECD Oncology Clinician will participate as an individual contributor on clinical study teams to meet enrollment and study delivery timelines and will work with other functional disciples as needed (e.g. Research Unit clinicians, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).

The individual will be involved with clinical drug development activities from FIH through PoC and will be a key member of clinical sub team(s) to ensure collaboration and seamless connectivity.

ROLE RESPONSIBILITIES

  • Responsibility to assist/lead execution of simple to moderately complex clinical studies; on more complex studies may support a lead clinician by taking responsibility for a portion of the overall clinical team’s deliverables.

  • Supports execution for post-FIH programs through PoM and PoC and able to operate independently on project teams, although, may need instruction on more complex or unusual study challenges and/or tasks.

  • Serve as technical support for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.

  • Attend select clinical sub team(s) meetings from FIH/PoM/ESoE through PoC trial completion to support development implementation and contribution to development milestones, e.g., start-up and delivery of ESoE and PoC trials.

  • Support or lead preparation or review of study-related documents, including but not limited to clinical protocol, study training documents, and regulatory documents.

  • Lead clinician data review efforts; on more complex studies may work with lead clinician to collect and collate safety data for safety review meetings.

  • Collaborate with the study team to maintain open communications and ensure successful study completion.

  • Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutics areas.

  • Accountable to multiple project/core study teams and clinical sub-teams and manages his/her own time to support the start-up, conduct, and close-out of individual clinical trial plans and processes.

  • Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice (GCP), regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes and apply knowledge gained within the Clinical Sciences group by way of process improvement and learning and serve as SOP subject matter experts.

  • Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to study start-up activities (e.g., IQMP, etc.) and apply lessons learned within the Clinical Sciences group.

  • Support and assist in the development of publications, abstracts, and presentations, as needed.

  • While generally not serving in an official manager role, may review the work of others within the group or serve in a mentoring role. 

  • Performs other duties as assigned related to clinical programs.

QUALIFICATIONS

  • Requires a minimum of a Bachelor’s degree in science or related science with at least 3-5 years’ clinical study experience OR MS degree and 2 years’ clinical study experience; clinician-type role or clinical operations-type role with a proven track record executing oncology clinical studies preferred.

  • Comprehensive knowledge of GCP and ICH guidelines.

  • Good understanding of the pharmaceutical/biopharmaceutical environment and drug development.

  • Strong interpersonal skills and team player with demonstrated ability to achieve work within ECD Clinical Sciences.

  • Project management skills preferred.

  • Strong organizational skills and ability to prioritize work a must.

  • Proficiency in MS Office: Word, PowerPoint, and Excel.

  
PHYSICAL/MENTAL REQUIREMENTS

  • Ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE OR TRAVEL REQUIREMENTS

  • Travel may be required (approximately 5-10% travel)

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.

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