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Director, Clinical Development, Infectious Diseases

Company: Moderna Therapeutics
Location: Cambridge
Posted on: February 19, 2021

Job Description:

Director, Clinical Development, Infectious Diseases Cambridge, Massachusetts Clinical Development The Role: Moderna is seeking a physician to lead clinical trials for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, and/or Pediatrics is desirable. Research and industry experience in vaccine development is a plus.-- This role will report to Moderna's Head, Translational Medicine, Infectious Diseases, and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review and interpretation 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 clinical scientific leadership in the clinical trial team.
  • Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
  • Either directly monitor or provide medical safety oversight of CRO medical monitors.
  • Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
  • Collaborate closely with partners in the Clinical Operations, and 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.
  • 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.
  • Comply with Moderna SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
  • 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 Internal Medicine, Pediatrics Family Practice, or Obstetrics/Gynecology.-- Completion of a fellowship, clinical research experience, 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
      • Demonstrated 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 written and oral communication skills to meet the needs of varied audiences.
      • Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable. Here's What We'll Bring to the Table:
        • On-site subsidized cafeteria or catered lunches
        • Company-provided iPhone
        • Free parking, monthly subway pass or a subsidized commuter rail pass
        • Free annual corporate membership to Bluebikes
        • 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
        • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
        • 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 (includes 2 floating holidays) About Moderna: In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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 - Posted 18 Days Ago Full time R3035 About Us Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Director, Clinical Development, Infectious Diseases, Executive , Cambridge, Massachusetts

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