Director, Clinical Development - Infectious Disease

Location
Cambridge, MA
Posted
Jun 12, 2022
Ref
R8406
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Role:

Moderna is seeking a board-certified physician to lead Clinical Development for one or more of their vaccine programs. Board certification in Pediatrics, Internal Medicine, and/or Family Medicine is desirable, and subspecialty training in Infectious Diseases is a plus.  Candidates with industry experience in vaccine development will be prioritized. 

This role will report to Moderna’s Vice President of Clinical Development, Infectious Diseases.  As the primary lead for medical oversight of clinical studies, responsibilities will include clinical trial design, protocol development, Sponsor oversight of medical monitoring, interpretation and reporting of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners.   The position is based at Moderna’s Cambridge, MA site. 

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines.  Excellence in communication, teamwork, and collaboration is a must. 

Here’s What You’ll Do:

  • Provide medical leadership for individual programs at the trial and project team level.

  • Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.

  • Either directly provide medical monitoring of trial safety or provide oversight of CRO medical monitors.

  • Collaborate with pharmacovigilance in the analysis of all clinical trial safety data.

  • Collaborating closely with Clinical Operations, be accountable for clinical trial conduct and timelines for associated key deliverables.

  • Lead the design and writing of clinical protocols and associated clinical documents.

  • Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.

  • Collaborating closely with the CRO medical monitor, be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.

  • Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.

  • Contribute to the writing of manuscripts and publications.

  • Assume primary responsibility for compliance with Moderna SOPs and adherence to ICH, GCP, and regulatory guidelines by the Clinical Team.

  • Provide medical leadership for internal audits and regulatory inspections.

  • Assist in preparations of materials for Advisory Board meetings.

  • Develop and maintain strong, collaborative relationships with the broader Moderna organization.

  • Represent Moderna externally to trial site Investigators and administrators.

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

  • MD or non-US equivalent of MD degree with completion of residency in Pediatrics, Internal Medicine, or Family Practice.   Completion of a fellowship or focused training in Infectious Diseases is desirable.

  • Minimum 3 years’ experience in early- to late-stage development in an academic or industry setting.  Proven ability to:

  • plan and conduct clinical trials

  • deliver high-quality results within established timelines

  • demonstrate a track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).

  • Ability to thrive in a fast-paced environment.

  • Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

  • Excellent analytical, problem-solving and strategic planning skills.

  • Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.

  • Exceptional communication skills to meet the needs of varied audiences.

  • Outstanding writing skills.

  • Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.

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-MD3

-