Vice President, Medical Affairs - Oncology/Hematology Medical Director

Vice President, Medical Affairs - Oncology/Hematology Medical Director

Syneos Health

Home-Based, Czech Republic

Summary:

Acts as a back-up to the Chief Medical Officer by serving as a Global leader in developing and maintaining a long-term vision and strategy to grow Oncology and Hematology Medical Affairs services to meet our customer needs while driving operational quality and efficiency. Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensures the scientific integrity of the clinical portions of clinical trials; provides medical input to clinical programs; provides clinical development and regulatory consulting advice as needed.

Essential Functions:

  • Assists Chief Medical Officer with successful management of the Business Unit’s (BU) Profit & Loss Statement (P&L);
  • Maintains expertise in the changing global Medical Affairs market by establishing, maintaining, and conveying a long-term vision and strategically integrating approaches to service delivery across global sites through organizational design;
  • Ensures that Medical Affairs operates in compliance with ICH-GCP and current relevant regulations (FDA, EMEA);
  • Generates new ideas and initiates best practices to further services provided to internal and external customers including therapeutic training;
  • Forecasts, prioritizes, and directs to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals, and profitable results. Anticipates staffing needs to conduct work;
  • Responsible for subject-safety and the scientific integrity of clinical trials;
  • Performs the duties of a Medical Monitor as required;
  • 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;
  • Provides clinical development and regulatory consulting advice both within the Company and to clients as requested;
  • Provides feedback to management on quality issues within the clinical trial team;
  • Represents the Company at scientific meetings and is the primary senior level contact for customers;
  • Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods;
  • Leads within the Medical Affairs team undertaking departmental and regional responsibilities as required. Creates, develops, and nurtures strategic client relationships to ensure a competitive market position.

Requirements:

Doctoral-level degree in medicine, and must have practiced medicine and have extensive clinical research experience, strongly focused on Oncology and Hematology. In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets for budgeting, 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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Syneos Health     Czech Republic     Clinical Research     Manager and Executive     Medical     Medical Advisor     Physician     Quality Assurance     Regulatory Affairs     5 Years+ Experience    

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies