Senior Manager, Oncology Early Stage Clinical Scientist (NonMD)

Pfizer, S.A. de C.V • Remote (MD, United States) • $200k - $250k / year • 1w ago

Senior Manager, Oncology Early Stage Clinical Scientist (NonMD)

United States - Washington – Bothell
United States - Pennsylvania - Collegeville
United States - New York - New York City
United States - Massachusetts - Cambridge
United States - Connecticut - Groton

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

ROLE RESPONSIBILITIES

Primary responsibilities in supporting the GDL in the execution of the clinical development strategy and plan for the assigned molecule(s)/indications(s).
Depending on experience, may lead the preparation of clinical protocol and may lead or support other critical documents, e.g., protocol amendments, investigator brochure, and regulatory documents.
Together with Clinical Operations, is responsible for timely execution of all FIH programs through proof-of-concept and delivering on innovative clinical study designs, high quality trial execution with Oncology Research Development (ORD), safety assessment and interpretation of clinical study results.
Conducts data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
In accordance with the Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead (or his/her delegate) and the GDL.
May support the transition early development clinical programs into late stage development, as appropriate.
In conjunction with members of the development team, may prepare presentations regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
Supports and assists in the development of publications, abstracts, and presentations.
May interface with safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators in such a way as to foster a transparent environment that encourages strong partnerships and mutual trust.
Supports the GDL and senior clinical scientist, in developing effective collaborations with project leaders and project team members.
Partners with Translational Oncology and Biomarkers as needed to ensure that biomarker plans to help determine early signs of efficacy and proof of concept, patient stratification, etc. are enabled.
In conjunction with the GDL and senior study clinician, may establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results.
Performs other duties as assigned related to clinical programs.

QUALIFICATIONS / SKILLS

Demonstrated experience in (and understanding of) oncology drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
Must have proven scientific writing skills and good communication skills.
Demonstrated experience with GCP and the ability to apply Pfizer policies and SOPs.
Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management.
PhD/PharmD and 2+ years; MA/MBA/MS and 5+ years; BA/BS/BSN and 7+ years of experience in clinical development. Two of these years should be in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone.
Data listing review experience.
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
Critical thinker who is proactive with a highly collaborative style and team-focused approach.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE OR TRAVEL REQUIREMENTS

5-10% Travel.

OTHER JOB DETAIL

Eligible for Relocation Package.

Eligible for Employee Referral Bonus.

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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