Sr. Director, Clinical Sciences
Reporting to the CMO, this person will be responsible for establishing Moderna's Medical Processes and Procedures and will be accountable for their execution across the Moderna drug development ecosystem.
Here's What You'll Do:
- Provide guidance for the development of global clinical science strategies.
- Lead workstreams to develop policies and procedures with cross-functional support.
- Review aggregate clinical data from clinical trials.
- Assure oversight for the medical review of safety events to ensure accuracy, integrity and completeness of clinical information.
- Contribute to the ongoing evaluation of the overall benefit-risk profile for investigational products, working in partnership with the Moderna Therapeutics' therapeutic areas to bring potential clinical issues to the attention of the medical team and upper management.
- Provide support for clinical documents, including the review of aggregate reports, protocols, final study reports, IB, and other documents, as needed.
- Provide input and review of responses to regulatory agency questions
Here's What You'll Bring to the Table:
- Master's degree and minimum 15-20 years experience in Biotech, Pharma or Clinical Research Organization.
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working with CROs, vendors, and relationship management preferred.
- Working knowledge of MedDRA dictionary with relevance to coding.
- Familiarity with common databases (e.g. ArisG, Argus, Oracle clinical, RAVE) preferred.
- Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
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.