Physician Project Leader, Immuno-Oncology Early Clinical Development

Company/Institution: GSK Pharmaceuticals
Department: Oncology Clinical Development / R&D
Location: Greater Boston or Philadelphia regions, MA, USA
Degree Requirements: MD, Board Eligible, Board Certified Salary: Not available
Job Type: Research, Other Posted: October 7, 2020
Job Setting: Corporate (Biotech or Pharmaceutical) Application Period: October 7-December 7, 2020

Responsibilities: - Strategic leadership for clinical development plans. - Management of critical resources and clinical project timelines. - Preparation, design, and/or review of clinical documents, e.g. protocols, investigator’s brochures, electronic case report form (e-CRF) design. - Immuno-oncology Clinical trial design and optimization. - Data optimization and oversight of eCRF creation, optimization, and finalization. - Participation in interpretation of data analyses of clinical trial results and developing clinical trial reports. - Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.) Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators. - Participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits. - Review safety data for routine medical data review, trend review, and safety signals from ongoing trials. - Review adverse event (AE)/ serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with GSK safety /the CRO safety team to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs. - Lead and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards). - Develop and manage relationships with key opinion leaders for clinical programs.

About the Employer

GSK Oncology has a strong commitment to the discovery and development of new innovative therapies for patients suffering from hematological malignancies or solid tumors, specifically in four cutting-edge areas of research: Cancer Epigenetics, Immuno-Oncology, Cell & Gene Therapies, and Synthetic Lethality.

How to Apply

Please either apply online using the "Apply Now" link below, or reach out to me for more details at 609-870-4541 (cell phone). I look forward to hearing from you!

Contact Information

Robert Mancuso
1250 South Collegeville Road
Collegeville, PA 19426 USA
https://gskoncologycareers.com
robert.j.mancuso@gsk.com

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