Director, Clinical Risk Management Strategy

The Role:

The Director, Clinical Risk Management Strategy will be responsible for leading and developing Modernas end to end Clinical Risk Management strategy inclusive of considerations for a Risk Based Quality Management (RBQM) framework. This is a leadership position within the Clinical, Processes, Compliance, and Inspection Readiness team. This role will work closely with Clinical Compliance and Inspection Readiness, Clinical Training and Process, R&D Quality, Central Monitoring and Oversight, Monitoring Strategy and Execution, and study teams. This is a highly collaborative and dynamic role within a fast paced and results oriented environment. Applicants should be outstanding team members with the ability to effectively lead a team and communicate and influence with internal and external stakeholders.

Heres What Youll Do:

• Drive Modernas strategy for Clinical Risk Management ensuring a holistic and system-wide approach, and inclusive framework is implemented and evolve it over time to meet the needs of the organization and reflect the changing industry landscape

  • Oversee risk management strategies and implement processes to ensure (a) identification of critical data and processes, (b) evaluation of likelihood, detectability, and impact of risks, (c) acceptability of risks and required risk reductions, (d) documentation and reporting of risks, and (e) review of effectiveness of risk control measures

• Define the systematic risk management and governance process including requirements for documentation, analysis, and performance trends across individual functions and across multiple projects/programs

  • Partner with the cross-functional teams to ensure appropriate actions are taken by study teams to investigate, resolve, and document new risks identified via data review, including adequate documentation of resolution

• Develop and champion learnings of the understanding of the interface between risk-based monitoring (RBM) and the larger RBQM framework

  • Develop and implement training across Clinical Development Operations (CDO) on RBQM and its elements

  • Serve as business process owner for RBQM procedures (SOPs, guidelines, policies, etc.) within Clinical Development Operations (CDO) and drive the development and optimization of standardized tools and guidance documents to support the study teams

  • Stay abreast of industry trends and intelligence regarding RBQM to ensure continuous improvement and evolution of Modernas systems and processes

• Collaborate with Monitoring Strategy and Execution, Central Monitoring Oversight, R&D Quality, and clinical trial teams on risk management framework and applicability and implementation across each function

  • Clinical Risk Management team is responsible for working with teams to perform the initial cross-functional risk assessment, ongoing cross-functional risk assessment as part of their management of the overall clinical risk assessment, control, and review process

  • Collaborate and provide input to the Central Monitoring Oversight and Monitoring Strategy and Execution teams on quality tolerance limits (QTLs) and key risk indicators (KRIs), centralized monitoring approach, on-site vs. remote monitoring, and SDV and SDR requirements

  • Maintain the internal risk, metrics, QTL, and KRI libraries

• Drive long term strategy and sourcing decisions to support a CRO-agnostic approach to RBQM

  • Responsible for determining outsourcing strategy and identification and implementation of related technologies and tools

  • Collaborate closely with CRO partners to oversee risk through adequate sponsor oversight

• Understanding the differences in strategies across multiple therapeutic areas and all phases of development and translate that into appropriate risk identification and management, inclusive of operational risks, across individual studies, programs, and the portfolio

• Lead, manage, and build out roles and responsibilities for a team of internal associates and functional service providers responsible for Clinical Risk Management

  • Includes line management responsibility for Clinical Risk Management associates

• Collaborate and ensure alignment with key stakeholders across the organization with responsibilities impacting risk management

Heres What Youll Bring to the Table:

• Bachelors degree required; advanced degree preferred

• Minimum of 10+ years of experience in clinical research and development, and at least 5+ years in roles focused on clinical risk management or RBQM

• Experience in implementing RBQM framework

• Knowledge and understanding of ICH GCP and other applicable guidelines

• Extensive experience with cross functional operational management and collaboration

• Extensive experience with compliance/risk management best practices

• Track record of establishing effective business relationships with internal and external customers

• Line management experience and demonstration of successful coaching, mentoring and development of team members

• Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe

• Ability to develop and evaluate business cases and effectively manage budgets

• Excellent written and verbal communication skills

• Excellent project management, leadership, communication, management, and organizational skills, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team building skills

• Flexibility to adapt to the dynamic needs of a growing company

• Solid understanding of drug development across all phases and multiple therapeutic areas

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary winter shut down
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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