The overall role of the Early Clinical Sciences (ECS) Clinician is to support the development and execution of one or more studies for small molecule and novel biological therapies from first in human (FIH) through proof of concept (Po. C) studies, including proof of mechanism (Po. M) and early signals of efficacy (E - So. E) studies in a given therapeutic area. The primary therapeutic areas for this position are Internal Medicine, Inflammation and Immunology, and Anti-infectives. The ECS Clinic... more details
ROLE SUMMARY
The overall role of the Early Clinical Sciences (ECS) Clinician is to support the development and 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 areas for this position are Internal Medicine, Inflammation and Immunology, and Anti-infectives. The ECS Clinician will participate as an individual contributor (often in partnership with another ECS clinician) on clinical study teams to meet enrollment and study delivery timelines. The ECS Clinician will work with other functional disciplines as needed (e.g. Research Unit clinicians/Global Clinical Leads/Medical Monitors, 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 development and 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 development and execution for 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, informed consent document, 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 and ongoing monthly data review per data review plan.
- 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. Apply knowledge gained within the Early Clinical Sciences group by way of process improvement.
- Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to the study (e.g., CORD, JReview, Signal Management etc.), and apply lessons learned within the Early Clinical Sciences group.
- Support and assist in the development of publications, abstracts, and presentations, as needed.
- May review/QC the work of others within the group.
- May serve in a mentoring role.
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 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 Early 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, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Travel may be required (approximately 5-10% travel).
Relocation support available.
Work Location Assignment: On premise
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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