Syneos Health - Germany

Medical Director - Oncology

Location
Home-Based, HUN
Salary
Competitive
Posted
30 Apr 2021
Closes
11 May 2021
Ref
20004897
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Summary:

You will interact with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; you will ensure the scientific integrity of the clinical portions of clinical trials; you will provide medical input to clinical programs; provides clinical development and regulatory consulting advice as needed. You will perform the duties of a Medical Monitor.

Essential Functions :
  • Manages subject safety and the scientific integrity of clinical trials.
  • Responsible for subject-safety and the scientific integrity of clinical trials.
  • Performs the duties of a Medical Monitor.
  • Provides some 24-hour coverage for clinical trials.
  • Participates in bids, bid-defenses & feasibility assessments when requested.
  • Provides project-specific and therapeutic training to sponsors and Company staff as needed.
  • Works with the Drug Safety Department by providing medical input and oversight.
  • Works with Medical Writing/Regulatory in the preparation of a variety of documents as required.
  • Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines.
  • Interacts with senior management, project management, and other departments as appropriate.
  • Provides clinical development and regulatory consulting advice both within Company and to clients as requested.
  • Locates and interacts with outside experts as necessary.
  • Provides feedback to management on quality issues within the clinical trial team
  • Represents Company at scientific meetings as required.
  • Primary senior-level contact for customers.
  • Assumes line-management duties as needed.


  • Other Responsibilities:

    Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).Requirements:

    Requires a doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. You should have training/experience in Oncology, with specific experience in one or more of the following: Solid Tumor, Hematology, Multiple Myeloma, Immuno-oncology. You should have an in-depth knowledge of worldwide drug-development regulations. You will need a strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined approach to work with excellent verbal communication and language skills. Fluency in written and spoken English is required.