Department: Pharmacovigilance and Drug Safety
Reports To: VP Pharmacovigilance and Drug Safety
MD. MD with advanced degree in epidemiology preferred.
Hours: 40 hours/week
Over-time may be required on occasion
General Description: The Executive Director, Safety Science manages and leads the function in PV and Drug Safety responsible for the identification, characterization and communication of the risks associated with BeiGene products under development and on the market and in concert with other functions developing and communicating risk mitigation strategies both internally and externally to regulators, clinical investigators and patients. The Executive Director will manage personnel in multiple domestic and international locations as both a line manager and as part of a management matrix.
Essential Functions of the job:
- Implement robust procedures for safety signal detection and evaluation including development of safety surveillance strategies
- Primary responsibility to manage content production of aggregate safety analyses including regulatory documents including ISS, DSUR, PBRER and other documents as required
- Answering ad hoc safety enquiries from regulatory authorities, ethics committees or drug safety monitoring committees that require analyses of the data
- Representing the Department to regulatory authorities and other outside groups concerning safety analyses of our drugs
- Managing the design and conduct of observational epidemiologic studies as needed
- Ensuring the communication of potential and identified safety risks to internal and external stakeholders
- Ensuring the provision of the CCSI for the CCDS
Supervise and mentor PV physicians and safety scientists in several domestic and international locations
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills: A knowledge of ARGUS a plus.
Other Qualifications: 15 or more years of progressive responsibilities in PV including data analysis and risk management activities. Strong managerial skills as evidenced by management of geographically distributed groups. Strong written and verbal communication skills. Experience in crisis management strongly preferred.
Travel: 10% primarily for site visits