VP, Clinical Safety and Risk Management (CSRM), Therapeutics and Oncology

The Role:

Reporting to the Chief Safety Officer, this highly experienced clinical safety physician will be responsible for all aspects of the clinical safety and risk management for all Moderna clinical development programs in the Oncology and Rare Disease therapeutic area. This senior safety clinical leader will oversee a team of safety physicians leading the Safety and Risk Management Teams for all products authorized or in development in this therapeutic area and will ensure the optimal continuous assessment of their safety profiles utilizing all available sources of safety data including clinical trials, post-marketing spontaneous safety reports, observational studies, Real World Data/Real World Evidence, and literature reports. In this role, this leader will ensure the proactive and transparent communication of risk information to regulatory agencies, prescribers and patients and will implement effective risk management measures as warranted. This position will work closely cross-functionally with senior leaders supporting these programs in Clinical Development, Regulatory Sciences, Clinical Development Operations, Biostatistics, PV Epidemiology/RWE, PV Operations, and other functions, and will be accountable for overseeing responses to safety queries from regulatory agencies and for the safety portion of regulatory filings.  This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. In addition, this role will oversee a team of safety review physicians who review individual case safety reports (including SUSARs) from all Moderna clinical trials across therapeutic areas and who provide our company causality assessment. 

This is an exciting time to join Moderna as we deliver the greatest possible impact to people through our mRNA medicines and vaccines; with a proven platform and a large and growing pipeline of products in clinical development Moderna is poised for substantial growth in the upcoming years.  This role will be a key contributor to and a member of our Clinical Safety and PV Leadership Team and will have the opportunity to make critical contributions to Moderna’s future success in making a transformative impact to patients using our mRNA platform.

Here’s What You’ll Do:

• 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.

Here’s What You’ll Bring to the Table:

• 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.

• Experience in epidemiology and observational research is preferred.

• 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