Medical Director Oncology
Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
We are currently seeking a Medical Director for our Oncology Business Unit to be based in Europe.
1. Provides scientific/clinical advice and oversight for medical aspects of projects
2. Collaborates with operational staff such as Project Directors, Project Managers and Monitoring teams. Consults with appropriate internal and external customers regarding clinical development and regulatory issues.
3. Manages subject safety and the scientific integrity of clinical trials. May performs the duties of a Medical Monitor, including provision of 24-hour medical coverage for clinical trials. Provides medical input and oversight in conjunction with the Drug Safety Department. Prepares of a variety of medically-related documents in conjunction with the Medical Writing and Regulatory departments, as required. May reviews and provides feedback on related documents prepared by less experienced colleagues.
4. May interact and collaborate with the Regulatory Affairs department regarding adverse event reporting and adverse event reports for NDAs and BLAs and other regulatory submissions, as required.
5. Participates in customer consultations, proposals, bids, bid-defenses, feasibility assessments, and Requests for Information (RFIs), as well as leads the proposal team with respect to medical and product development activities.
6. May provide project-specific and therapeutic training to Sponsors and Company staff as needed.
7. May present feedback and proposes recommendations to management on quality issues within the clinical trial team.
8. Represents the Company at scientific and industry meetings as required, including participating at booth exhibitions, speaking, etc. May represent the Company by publishing scientific or industry-related articles in industry and clinical journals.
9. Locates and engages outside therapeutic experts/consultants/advisors as necessary to provide medical/scientific input if required
10. May contribute to development of product/clinical development plans, and collaborate with respective client and internal departments regarding other reports, applications and regulatory submissions.
11. May guide the work of and/or support less experienced colleagues.
12. Maintains an in-depth knowledge of FDA and worldwide drug-development regulations.
To succeed in this role you will need the following skills/experience:
• Doctorate degree in medicine and significant clinical experience in the practice of oncology area
• Significant clinical research and demonstrated leadership experience in oncology area.
• A strong understanding of the use of medical terminology and of drug-names in multiple nations and environments.
• Experience working in matrix-teams is preferred.
• Effective organizational and interpersonal skills, communication and language skills, and group presentation skills. Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills.
• Ability to be customer-focused and have a disciplined approach to work is critical
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees