Director, Compliance, Clinical Development
In this new role, the successful candidate will provide strategy and oversight of clinical trial/program compliance. The candidate will work to support clinical teams across different stages of development and across therapeutic areas. The successful candidate will be skilled at both understanding and applying global compliance regulations and processes to trials as they advance through clinical development. The position requires a collaborative partnership with cross functional team members across the organization. The candidate will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution oriented to ensure standards, processes and work instructions are built with the needs of the business.
Here's What You'll Do:
- Collaborate with Clinical Development to ensure all trials are conducted in compliance with global regulations, ICH/GCP and applicable business processes and practices
- Review work and workflows of teams to ensure clinical compliance and provide guidance on training or improvement in processes
- Keep abreast of regulatory developments across industry as well as evolving compliance best practices
- Ensures an effective training program is maintained for all required compliance/regulatory training.
- Collaborate with client stakeholders to answer compliance questions or direct compliance issues to appropriate subject matter experts
- Ensure that compliance issues associated with clinical audits are properly evaluated and adequately addressed in collaboration with Clinical QA.
- Coordinate assessments of line functions to ensure adherence to stated policies/standards and lead associated work streams as needed
- Track and report on KRIs/KQIs for Clinical Development
Here's What You'll Bring to the Table:
- Bachelor's degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
- At least 10 years experience in clinical research with direct clinical compliance oversight
- Excellent written and oral communication skills
- Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
- Good organizational/prioritization skills for the management of clinical development compliance
- Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
- Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with cross-functional teams and will be relentless in pursuing successful quality outcomes
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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.