Director, Global Clinical Lead, Rare Disease
Moderna is seeking an experienced physician scientist design and execute rare disease drug development studies for their mRNA-based programs. This role will report to the Chief Medical Officer and have direct medical responsibility for rare disease development programs, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with Moderna's internal clinical research and platform organizations and relevant external pharmaceutical partners.
The successful candidate will thrive in a proactive, fast-paced ‘can-do' culture and enjoy collaborating across the full range of development activities for the ground-breaking, mRNA-based new drug candidates targeting rare disease, in addition to being a highly-effective internal and external team player and terrific communicator and relentless contributor.
Here's What You'll Do:
- Provide clinical leadership for rare drug discovery and development, serve as top representative for clinical development / medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff)
- Act as subject matter expert on all clinical and medical strategic initiatives
- Design and develop clinical development plans, study protocols and interpret clinical study data, including review of the pre-clinical package
- Consult with external and internal subject matter experts to agree go/no-go development decision criteria
- Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues
- Lead clinical sections of regulatory documents (e.g., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA, EMA and other healthcare authorities and organize and prepare for Clinical Advisory Board meetings
- Serve as an exemplary leader; mentor, train and develop cross-functional staff, as needed
- Medical leadership on rare disease clinical trials with adherence to cGCP and Regulatory compliance
- Represent the Company externally to Investigators and trial site administrators
- Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization.
Here's What You'll Bring to the Table:
- MD or MD/PhD a minimum of 5 years of demonstrated knowledge and experience in clinical research in rare disease as well as significant knowledge and experience in the design and execution of clinical trials
- Demonstrated track record in leading cross-functional teams and work streams (e.g., biostatistics, regulatory, pre-clinical pharmacology and pharmaceutical sciences)
- Demonstrated scientific accomplishment enabling rapid understanding of the mRNA technology.
- Marked proficiency in clinical/medical writing and verbal communication
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution
- Experience in early-stage programs
- Experience in leading the selection and oversight of CROs and other vendors
- Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct
- Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
- Experience in regulatory cGCP inspections and audits
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Creative, capable and relentless problem-solver
- Track record of dogged pursuit of solutions for patients
- History of taking bold, but calculated risks
- Common sense.
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?
We are pioneering a new class of medicines made of 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 website (Modernatx.com) 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.