The Associate Director, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance and Inspection Readiness. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and applying internal procedures and policies as well as local and global regulations and processes to trials as they advance through development. The position requires a collaborative partnership with cross-functional team members across the organization.
Heres What Youll Do:
Collaborate with cross-functional clinical trial teams to ensure all trials are conducted in compliance with internal policies and procedures, global and local regulations, and ICH/GCP
Represent Clinical Compliance on clinical trial teams
Identify compliance risks, communicate risks, facilitate appropriate decision making with impacted functions, and escalate to management
Collaborate with cross-functional team members to answer compliance questions or direct compliance issues to appropriate subject matter experts
Keep abreast of regulatory developments across industry as well as evolving compliance best practices
Ensure that compliance issues associated with clinical audits or inspections are properly evaluated and adequately addressed in collaboration with study teams and R&D Quality
Support study teams with reporting of quality events, investigation of issues, root cause analysis, and CAPA plans
Promote inspection readiness with trial teams and ensure teams are trained and prepared for inspections
Heres What Youll Bring to the Table:
Bachelors degree required; Advanced degree preferred
Minimum of 8 years of experience in clinical research with 4+ years of direct responsibility and experience in clinical compliance and inspection readiness
Excellent written and oral communication skills
Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
Outstanding verbal and written communication skills
Ability to manage multiple projects 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 year-end shutdown
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!
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 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 proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)