VP, Clinical Safety and Risk Management (CSRM), Therapeutics and Oncology
VP, Clinical Safety and Risk Management (CSRM), Therapeutics and Oncology
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1 Vacancy
Job Description
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 Modernas future success in making a transformative impact to patients using our mRNA platform.
Heres What Youll 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.
Heres What Youll 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 safety and pharmacovigilance expertise with exceptional leadership (strategic thinking people and resource management)
Ability to embrace Modernas culture values and mindsets.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.
- Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.
Our Working Model
As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens U.S. lawful permanent residents asylees or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered contingent on the companys ability to obtain any required export control license.
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Required Experience:
Exec
Employment Type
Full-Time
