Executive Director, Pediatric and Maternal Vaccines, Infectious Disease

Location
Cambridge, MA
Posted
May 31, 2022
Ref
R6385
Required Education
Bachelors Degree
Position Type
Full time

The Role:

Moderna is seeking a M.D., preferably with specialization in Pediatrics, Obstetrics and Gynecology, and/or Infectious Disease, to lead vaccine clinical development for pediatric and maternal vaccines.  This role will report to the SVP, Clinical Development, Infectious Disease for Moderna and have direct medical responsibility for the clinical development of a portfolio of vaccines, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners, Clinical Research Organizations and regulatory agencies. This role will have a strong external scientific engagement component and represent Moderna’s interests at meetings with scientific, public health, and policy-making bodies internationally. The position will be based in Cambridge, MA headquarters or at one of the East Coast satellite sites. There is up to 25% travel expected as part of this role.

The successful candidate will be able to work independently and thrive in a proactive can-do culture and team milieu.  The role will have 1-3 direct reports, and will also involve leadership through influence on cross-functional teams.  The candidate will be a highly-effective internal and external team player and terrific communicator and collaborator.

Here’s What You’ll Do:

  • Provide clinical leadership for mRNA pediatric and maternal vaccine programs at the Program Team Level.

  • Serve as the key development representative both internal- and external-facing stakeholders [e.g., Clinical Research Organization (CRO), Key Opinion Leader (KOL), Data and Safety Monitoring Boards (DSMBs), the Advisory Committee on Immunization Practices (ACIP), etc.]

  • Serve as cross-functional leader for Clinical work streams in the mRNA pediatric and maternal vaccine programs.

  • Design clinical development plans and study protocols, and interpret and analyze clinical study safety and efficacy data, including review of the pre-clinical package.  Responsible signatory for Investigator Brochures, Clinical Study Reports, regulatory submissions and responses pertaining to clinical development, and other program documents.  In partnership with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.

  • Consult and collaborate with other senior leaders in the Moderna organization, including the Head Vaccine Strategy, Head Regulatory Affairs, Head Medical Affairs, Head Safety and Pharmacovigilance, and Chief Medical Officer.        

  • Prepare meeting abstracts, posters, presentations related to clinical trial data for internal management review and external scientific/clinical meetings.

  • Establish go/no-go development decision criteria to enable best decisions for the mRNA vaccine programs. 

  • Serve as a peer-review subject matter expert for the study protocols and clinical development plans for other mRNA projects.

  • Accountable for safety monitoring of clinical trials, including regular review of safety data (including but not limited to SAEs) and responses to safety issues. 

  • Lead author for clinical sections of regulatory documents [e.g., Investigational New Drug (IND) application, Drug Master File (DMF) and Biologics License Application (BLA)/ New Drug Application (NDA)], prepare for meetings with FDA and healthcare authorities and organize and present to Vaccines and Related Biological Product Advisory Board (VRBPAC) meetings.

  • Implement clinical trials with adherence to cGCP and compliance with FDA, EMA and other relevant national regulatory agency requirements. 

  • May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Research and Development and Technical Development colleagues to design and implementation of translational strategies.

  • Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization

  • Lead communications of the clinical development progress, updates and analysis of clinical data to Moderna senior management reviews, e.g. Executive Committee, Protocol Review Committee and others.

  • Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct, interact constructively with Safety or Data Monitoring Committees.

Here’s What You’ll Bring to the Table:

  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant infectious disease/pediatric training.

  • Recognized expertise in the fields of maternal immunization and pediatrics.

  • Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development)

  • Outstanding verbal and written communication skills, in addition to excellent organizational skills

  • Strong experience in the vaccine development process and the conduct of clinical trials, including clinical and non-clinical study design, use of immunologic surrogates, assay development and GCP certification. 

  • Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of clinical studies in the United States, Europe and rest of world.

  • Experience in regulatory cGCP inspections and audits.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes 
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    •    Vacation, sick time and holidays
    •    Volunteer time to participate within your community
    •    Discretionary winter shut down 
    •    Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

#LI-KF1

-