Associate Director, Clinical Drug Supply Management
Moderna is seeking an Associate Director of Drug Supply Management to manage the clinical drug supply needs across its clinical projects as well as to work with packaging and labeling and IRT vendors and CROs. This position reports to the Moderna's Head of Clinical Operations. This position will work collaboratively across several therapeutic area teams as well as cross functionally to support the study needs. This position will drive process and best practice for clinical drug supply. The successful candidate will be skilled at understanding the needs of the teams with attention to detail with a collaborative outlook and with the ability to manage workload to meet project timelines. This position will have direct reports.
Here's What You'll Do:
- Drive best practice for supply logistics and for the processes surrounding the supply
- Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies necessary
- Oversee process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
- Manages work with labeling and packaging vendors, Functional Leads
- Primary interface with CMC for Production Planning & Distribution; develops best practice for forecast of all drug supply needs
- Implements Industry Best Practices and templates for clinical drug supply activities.
- Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments as well as the workload of drug supply managers in the group
- Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution.
- Develop pharmacy manual in conjunction with relevant cross functional leads
- Develop drug and clinical supply training materials for investigational sites
Here's What You'll Bring to the Table:
- At least 8 years of clinical supply management experience in a clinical research environment and 5 additional years overall clinical operations experience
- Bachelor's degree in a science-based subject (advanced degree preferred)
- Prior Cold Chain distribution experience required.
- IRT implementation experience
- Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
- Demonstrated 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 multifunctional teams and partners and will be relentless in pursuing successful 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
- 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.