Scientist Clinical Trials - Oncology - Thoracic; Sr. Manager

Position: Scientist for Clinical Trials - Oncology - Thoracic (Sr. Manager)
Location: Chesterton

The Scientist for Clinical Trials - Oncology - Thoracic (Sr. Manager)( non-MD ) is responsible for providing support of scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio .

Job Responsibilities Clinical development professional maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. 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). 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. Reviews and queries safety and efficacy data in support of the clinical data review strategy and 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).

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- and enterprise level work groups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure. May supervise, mentor, and/or develop others.

Promotes team health and exemplifies Pfizers leadership behaviors and actionable attitudes. Leverages a variety of communication tools and techniques to communicate results. Builds partnerships across the company to achieve the needs of the program. Collaborative problem solving (handles conflict constructively) Promotes innovation and takes appropriate risks to challenge the status quo to enhance the efficiency of current processes. Ability to work proactively and independently, organize tasks, time and priorities of self and others.

Qualifications/Skills Science degree (PhD, Pharm

D, or equivalent) and some relevant experience Clinical Research experience in industry/CRO. Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor. 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. 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 solid understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance. Proficient with basic IT; efficiently using a computer and telecommunications (voice and video). Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned.

Demonstrates effective problem-solving, and agile…