VP – Clinical Safety and Risk Management – Csrm – Therapeutics and Oncology
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA, Princeton, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Expert or higher |
Requirements
- M.D. with a minimum of 10 years of industry experience in relevant areas (Clinical Development, Epidemiology, Medical Affairs, Scientific Affairs, Regulatory Affairs, or PV), including at least 5 years of senior leadership experience overseeing clinical safety and risk management for oncology and/or rare disease programs.
- Extensive experience overseeing and managing clinical safety both in the pre-authorization and in the post-marketing phase.
- Strong medical and scientific skills and a track record of successful teamwork cross-functionally and cross-regionally.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
- Excellent interpersonal and communication skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
- Ability to manage multiple deliverables and initiatives in a fast-paced environment.
- Ability to combine clinical safety and pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management)
- Ability to embrace Moderna’s culture, values and mindsets.
Responsibilities
- Provide dynamic leadership, strategic direction, and global oversight of all aspects of the clinical safety assessment and risk management of all Moderna clinical development Therapeutics and Oncology programs.
- Provide direct oversight to safety physicians supporting programs and leading Safety & Risk Management Teams for clinical development programs in the Therapeutics and Oncology TA.
- Work closely with our pharmacoepidemiology/RWE staff to ensure the successful design and execution of all observational Post-Authorization Safety Studies for these programs.
- Partner closely with senior cross-functional colleagues in developing the strategies and supporting the execution of the clinical development and registrational plans for Therapeutics and Oncology programs.
- Represent Clinical Safety and Pharmacovigilance at governance meetings for Therapeutic and Oncology products.
Preferred Qualifications
- Experience in epidemiology and observational research is preferred.