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Job Details

Global Medical Director, Clinical Development Immuno-Oncology @ Fast Growing Biotechnology Company – Belgium

Company: Advanced Clinical Recruitment Ltd
Location: Belgium
Reference: MedOnology784747
Closing Date: 31 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: TBD

Job Summary:

A Leading Global Biotechnology Company has retained our services to identify a Global Medical Director, Clinical Development Immuno-Oncology based at their International HQ in Belgium. Our client partners with recognized industrial and academic partners in the development of novel therapies in phases I-III.

Requirements:

Responsibilities

Provide leadership throughout clinical trials in the Immuno-Oncology CAR-T cells area.

You will be responsible designing and/or managing the implementation of the clinical strategy within Clinical Development globally. Duties include:

  • Develop clinical trial strategies, design study protocols, monitor, document, and interpret clinical study data. You will ensure projects adhere to Good Clinical Practice and regulatory requirements.
  • Implement safety strategy across studies, including regular review of safety data and response to safety issues including communications with investigators and regulatory agencies. Compliance with all pharmacovigilance (PVG) regulations and guidelines. 
  • Review AEs, SAEs, lab data, tables, listings, & graphs; provide medical assessment and instruct staff in appropriate query and follow up activities.
  • Perform medical assessment for expedited reporting, IND & EU annual reports, FDA Periodic Reports, and Periodic Safety Update Reports, SUSAR reporting, etc.
  • Lead medical sections of regulatory documents in EU and US; assist team with preparations for regulatory agency meetings and reports, including patient and safety narratives.
  • Provide medical support to clinical operations team. Interface with the Program
  • Director & R&D Leaders (to ensure milestone realization and resource optimization).
  • Represent Celyad in meetings with health authorities, the scientific community, and international agencies as needed.
  • Publish clinical data in peer review journals and present in external scientific meetings/congresses.
  • Responsible for follow-up of project related literature.
  • Manage Key Opinion Leaders , Clinical Steering Committee and Advisory Boards
  • Travel up to 10% of his/her time

Qualifications 

  • Medical degree and experience as a physician or academic (Oncology Specialist desirable)
  • Experience working within Immuno-Oncology is highly desirable
  • 3 to 5 years clinical experience in biopharmaceutical, biotechnology industry
  • Sound scientific background required to critically evaluate all scientific aspects of oncology / immunology
  • Knowledge of clinical stage drug development efforts, including typical hurdles and challenges, and experience in mitigation strategies.  Experience in designing, monitoring and implementing clinical trials and interpreting trial results
  • Experience interpreting clinical data and managing safety strategy
  • Experience preparing and reviewing documents for clinical development to ensure high-quality document submissions health authorities and regulators (knowledge of biomedical research regulation)
  • Knowledge of assays and metrics for safety, clinical, and clinical outcomes
  • Experience of cross-functional team with diverse skill sets (matrix organization)

 

Keywords: Medical Director, Clinical Development, Associate Medical Director, Medical Lead, Clinical Lead, Senior Medical Director, Clinical Research Physician, Safety Physician, Medical Affairs, Clinical Research, Oncology, Immuno-Oncology, Global, European, Phase I. 

Apply for this job: Global Medical Director, Clinical Development Immuno-Oncology @ Fast Growing Biotechnology Company – Belgium

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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