Clinician NonMD Senior Manager

Pfizer
Remote, Remote, United States;
Competitive
October 06 2022
4864412
Full Time
Pharma
Manager
Are you an accountable, adaptable clinician with strong experience designing and delivering clinical trials and the desire to develop a long-term career in biopharmaceuticals with a leading name in the field? Then Pfizer has the ideal opportunity for you. A role at Pfizer will offer you the opportunity to own a career with real impact and comes with vast opportunity for growth.

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Whatever the disease, our 25,000 clinical researchers are turning advanced science and technologies into the therapies that matter most. Their efforts are one of the greatest human endeavors. Now, we want you to join our uniquely collaborative global community of first-class talent.

Working in the Clinical Development and Operations (CD&O) department, you will be accountable for the medical and scientific integrity of studies and the wellbeing of patients enrolled in clinical trials. Your challenge? Independently or in collaboration with other clinicians, to efficiently design and effectively execute high quality clinical studies in close partnership with Clinical Operations. Importantly, you will have an opportunity to meaningfully contribute to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

Examples of your responsibilities include:
  • Maintaining compliance with internal and external standards, mitigating risk and managing emerging clinical issues within the trial, and being the primary contact for external investigators and internal study team members for questions relating to clinical/medical aspects of the protocol.
  • Timely delivery of the governance approved protocol which maximizes operational efficiency, trial quality and participant / site engagement and which minimizes the likelihood of amendments or quality issues.
  • Provide clinical input to the data collection and analysis tools to ensure application of data standards, optimized data collection and both timely and thorough review of data through the use of clinical data review best practice.
  • Support the country and site selection process, develop protocol specific training, participate in investigator meetings.
  • Author and manage approval of Informed Consent Documents (ICDs) and protocol amendments, accountable for Data Monitoring Committees (DMCs) and endpoint adjudication committees, responsible for review and management of protocol deviations.
  • Provide input to Risk Management and Safety Review Plan, reviews safety data and updates study documents as appropriate, tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
  • Support appropriate interpretation and communication of data, including the Clinical Study Report, narratives and primary publication of clinical trial results.
  • Collaborate with cross-functional colleagues across our global network and may also travel from time to time.


Requirements:

In addition to a BA/BS, you will need at least four years of experience and a track record of success in the biopharmaceutical industry in clinical research and development. We are looking for extensive knowledge of clinical development, global and regional regulation, ICH/GCP and adverse event management, as well as strong administrative, project management, and leadership skills. A strong advocate for creating a strong morale and a tight knit team with an open dialogue, you will be able to take personal responsibility for results and be able to push yourself and others to exceed your goals and deliver excellent results.

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

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.

Eligible for Employee Referral Bonus: YES

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Relocation assistance may be available based on business needs and/or eligibility.

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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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