Associate Director, Clinical Compliance
- Moderna, Inc.
- Cambridge, MA
- Start date
- Mar 22, 2023
- Clinical, Clinical Research, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Genetown, Best Places to Work
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!
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.
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.#LI-MM1
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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