Head, Clinical Development, Infectious Disease
Moderna Therapeutics is seeking a Head of Clinical Development, Infectious Diseases to lead the development clinical strategy for its infectious disease team. This role, reporting directly to the CMO, will be focused on establishing the development strategy and will work closely with members of the CMO's leadership team in establishing clinical endpoints, development protocols, safety reviews and regulatory strategies and interactions. The position is responsible for providing medical guidance during the design, execution, and reporting of clinical studies.
Here's What You'll Do:
- Serve as cross functional leader on all Medical and clinical work streams. Subject matter expert on all clinical and medical strategic initiatives
- Accountable for the design and authorship of study protocols and interpretation of clinical study data.
- Lead clinical sections of regulatory documents (IND, DMF, BLA/NDA). Prepare for meetings with FDA and healthcare authorities; Organize and prepare for Advisory Board meetings.
- Oversee and directly contribute to the clinical development plan clinical compounds, includes review of the pre-clinical package, review and endorsement from key stakeholders for go/no-go development decision criteria.
- Provide clinical leadership for franchise, serve as top representative for clinical development/ medical strategy areas both internal and external facing(ex, CRO, KOL , Clinical site staff).
- Drive cross functional groups and activity: Pharmacology, Statistics, Regulatory Affairs, Clinical Operations, etc.
- •Serve as an exemplary leader; Mentor, Train, and develop staff as needed
Here's What You'll Bring to the Table:
- MD/DO/MBBS with a minimum of 12 years of demonstrated knowledge and experience in vaccines or Infectious disease clinical development in an industry setting as well as significant knowledge and experience in the design and execution of clinical trials, including all phases of clinical research
- Demonstrated track record in leading cross functional teams and work streams (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific accomplishment; well versed in current technology
- Marked proficiency in clinical/medical writing and verbal communication
- Demonstrated track record in managing a cross functional team
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.Our Mission:
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.