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Oncology Late Stage Clinical Scientist (Senior Manager, Non MD)

Oncology Late Stage Clinical Scientist (Senior Manager, Non MD)

PfizerGroton, CT, US
2 days ago
Job type
  • Permanent
Job description

POSITION SUMMARY

You will

be responsible for

scientific oversight, data

integrity

and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.

KEY RESPONSIBILITIES

Clinical development expert for assigned studies

maintaining

current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.

Responsible for scientific oversight, data

integrity

and quality of

the clinical

trial(s).

Represent the study team in governance meetings and submissions, partners with / supports the Development lead / Medical Director

regarding

study and disease area strategy.

Author protocols, study level informed consent documents, and

contributes

to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings,

participates

as

appropriate

Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to

appropriate teams

, governance bodies, and other internal and external stakeholders.

In close partnership with medically qualified

colleague / s

, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).

Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable

trainings

, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing

PFE clinical

development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

MINIMUM QUALIFICATIONS

PhD / Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry / CRO, OR

MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry / CRO OR

BA / BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry / CRO

Clinical Research experience in the phase 3 / pivotal space in Oncology, ideally on the side of the sponsor and with

a track record

of successful regulatory submission, inspection, and regulatory approval.

Excellent knowledge of clinical procedures, ICH guidelines,

GCP

and familiarity with FDA, EMA, and global regulations.

Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance.

Experience working on large data sets.

Proficiency

with Microsoft Office and relevant scientific software

Effective communication, presentation, and organizational skills to ensure coordinated and

timely

delivery.

Experience

leveraging

a variety of communication tools and techniques to communicate results

Experience solving problems collaboratively and handling conflict constructively.

Track record

of scientific productivity as

evidenced

by publications, posters,

abstracts

and / or presentations.

Experience working proactively and independently, organizing tasks, time and priorities of self and others.

Experience building partnerships across the company to achieve the needs of the program.

PREFERRED QUALIFICATIONS

Experience in Hematology Oncology

COMPETENCIES FOR SUCCESS

Demonstrates passion for helping patients with cancer and for the science of oncology.

Flexibility to adapt and navigate through an ever-changing work environment while

maintaining

integrity and quality in the work assigned.

Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities.

Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes.

Leverages knowledge and support from others related to overall

objectives

, strategy, critical issues, and policies.

Demonstrates foresight and judgment to make complex decisions

Promotes innovation and takes appropriate risks to challenge the status quo

in order to

enhance the efficiency of current processes.

Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development

Has

a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and

geographies

  • . both as a leader and a key contributor

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 :

This is a Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.

Pfizer endeavors to make

www.pfizer.com / careers

accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing, please email

disabilityrecruitment@pfizer.com

  • . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and / or interviewing. Requests for any other reason will not be returned.
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