Late-stage Clinical Scientist - New York, United States - Pfizer

Pfizer
Pfizer
Verified Company
New York, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description

ROLE RESPONSIBILITIES

  • The Late-Stage Clinical Scientist (Director) is a clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Effectively partners 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).
  • Represents the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
  • Authors 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.
  • Sets the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
  • In close partnership with medically qualified colleague/s, analyzes 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).
  • If medically qualified, assumes medical monitoring responsibilities.
  • Follows 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
  • May have managerial responsibility for other clinicians or contingent workers assigned to the project; may supervise, mentor, and/or develop others.

QUALIFICATIONS

  • Science degree (PhD, PharmD) and minimum of 9 years Clinical Research experience 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.
  • Demonstrates a passion for helping patients with cancer and for the science of oncology.
  • Proven analytical skills with the ability to work on large data sets.
  • Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
  • Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English; scientific productivity via publications, posters, abstracts and/or presentations.
  • Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development; proficient with basic IT; efficiently using a computer and telecommunications (voice and video)
  • 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; works effectively with internal and external partners and investigators/medical professionals.
  • Has extensive understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, preclinical, pharmacology, quality assurance.
  • Has the flexibility to adapt and navigate through an everchanging work environment while maintaining integrity and quality in the work assigned.
  • Must have the relevant personality features and competencies supporting the responsibilities:
  • Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities.
  • Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies.
  • Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development.
  • Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes.
  • Has foresight and judgment in complex decisions.
  • Leverages a variety of communication tools and techniques to communicate results.
  • Efficiently builds partnerships across the company to achieve the needs of the program.
  • Solves problems collaboratively and handles conflict constructively.
  • Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes.
  • Ability to work proactively and independently, organize tasks, time and priorities of self and others.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel 10% or less; mostly national, rarely international.

Must be on-site at one of the
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