Senior Director, Business Operations, Clinical Development
In this new role, the successful candidate will lead a range of operational activities to develop and optimize processes for Moderna clinical development teams. This role reports to the Head of Clinical Operations. The clinical development processes will support cross functional teams from early phase as they progress through development. Responsible for driving the consistency and governance of processes through close collaboration with stakeholders to sure ensure the delivery of cross functional development operations 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 role will have direct reports leading specialty delivery areas.
Here's What You'll Do:
- Optimize feasibility processes to ensure the generation of early operational planning
- Provide strategic input into the development and implementation of clinical development optimization processes through leading process initiatives and change management activities
- Oversight and reporting of Clinical Development Metrics and Key Indicators
- Drive the consistency and governance of clinical development optimization processes through leadership of continuous improvement activities and the development and delivery of training.
- Lead outsourcing management and vendor oversight strategy and implementation for Clinical Development
- Develop and maintain knowledge of external clinical trial trends and assess developments for impact on clinical development
- Manage clinical development technology integrations with the functional development leads
Here's What You'll Bring to the Table:
- Bachelor's degree in a life science or allied health discipline (e.g. nursing, medical or laboratory technology); Advanced degree preferred
- At least 15 years experience in clinical research
- Solid understanding of project management methodology including process mapping
- Strong written and oral communication skills including negotiations
- Previous technology integration and implementation experience
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
- Strong organizational/prioritization skills for the management of multiple concurrent projects with strong attention to detail
- 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 cross-functional teams 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.