Sr. Director, Clinical Processes and Compliance, CDO

The Role:

The Senior Director, Clinical Processes, Compliance, and Inspection Readiness is a leadership position within Clinical Trial Excellence and Support. The position is responsible for leading the team and driving activities across Clinical Development Operations (CDO) related to Clinical Compliance, Inspection Readiness, Clinical Training and Process, and Clinical Risk Management Strategy. The successful candidate will provide direction and oversight to ensure Moderna is compliant with all applicable SOPs, policies, and regulations, and inspection ready at all times. Applicants should be highly collaborative team members with the ability to effectively influence, lead, and communicate with internal and external stakeholders at all levels.

Heres What Youll Do:

• Lead and retain accountability internally to ensure development, alignment, and maintenance of information, best practices, and to standardize processes

• Responsible for the leadership and oversight for Inspection Readiness activities by building it into the development process to ensure Moderna is always inspection ready and able to act agilely for any inspection/audit in a timely manner, including proactive and ongoing partnership with the R&D Quality (RDQ) organization

• Collaborate with Digital and cross-functional leaders and stakeholders to identify and implement strategic initiatives, processes, and solutions to support Clinical Compliance, Inspection Readiness, Clinical Training and Process, and Clinical Risk Management Strategy activities

• Provide expertise and guidance across the organization regarding global regulations, ICH/GCP and applicable business processes and practices

• Lead, manage, and build out roles and responsibilities for a team of internal associates and functional service providers for Clinical Compliance and Inspection Readiness, Clinical Training and Process, and Clinical Risk Management Strategy

  • Line management responsibility for functional leaders within Clinical Compliance and Inspection Readiness, Clinical Training and Process, and Clinical Risk Management Strategy

  • Drive hiring and retention strategy to build and develop high performing teams

• Responsible for prioritization of activities and strategy-based decision making around compliance issues, development and execution of effective and inclusive action plans, and appropriately and proactively liaise with the broader organization

• Maintain ownership and drive Modernas strategy for Clinical Risk Management ensuring a holistic and system-wide end-to-end approach and inclusive framework is implemented

• Drive a culture of continuous improvement and quality, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality

• Build and maintain strategic relationships with teams and relevant internal and external stakeholders including functional heads to support best practices, create, and improve on process, SOPs, and training

  • Responsible for driving with the Moderna team the approach to oversight and management of CRO partners and other external vendors in outsourced activities that directly impact clinical trials through Clinical Compliance, Inspection Readiness, Process and Training, and Clinical Risk Management

Heres What Youll Bring to the Table:

• BA/BS required; Advanced degree preferred

• Minimum of 15+ years of experience in a clinical research environment within the pharmaceutical and biotech industry, at least 5+ years in a leadership role focused on Clinical Compliance, Inspection Readiness, Training and Process, and/or Clinical Risk Management

• Direct experience and responsibility for leading, establishing, and implementing process-driven frameworks for all aspects of Inspection Readiness in a GxP environment

• Experience in building high performing teams and developing team members to be future leaders

• Solid understanding of appropriate regulations and guidelines (ex. FDA and ICH GCP guidelines) and applicability with clinical trials

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

• Outstanding verbal and written communication skills

• Ability to manage multiple projects and competing priorities in a fast-paced environment

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

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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