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Sr. Director, Program Leader, Infectious Disease - RSV Older

Company: Moderna Therapeutics
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Sr. Director, Program Leader, Infectious Disease - RSV Older Adult Cambridge, Massachusetts Clinical Development The Role:The Infectious Disease Therapeutic Area at Moderna is responsible for leadership and management of the clinical-stage programs in vaccines and monoclonal antibodies from IND to licensure. Moderna is seeking a motivated and energetic Program Leader for the RSV Older Adult vaccine program to drive the program strategy and maintain accountability of program execution. The successful candidate will work in close coordination with the Program Manager to enable the execution of the set timelines with high quality and scientific integrity. The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, bioassays, CMC, non-clinical, and medical to deliver against the program strategy through Phase 3 and the BLA submission into life cycle management. The successful candidate will have experience in late-stage readiness and development of vaccines.About the RSV Older Adult vaccine program (mRNA-1345):Respiratory Syncytial Virus (RSV) is a respiratory virus which normally causes mild-to-moderate cold symptoms, but can cause more severe respiratory disease in at-risk groups such as young infants and older adults. To date, no vaccine to prevent infection has been approved. Moderna is developing mRNA-1345, and RSV vaccine based on an mRNA sequence encoding a modified version of the F protein stabilized in its more immunogenic, prefusion confirmation. mRNA-1345 is currently in Phase 1 of clinical development. Here's What You'll Do : The Program Leader will be involved in high-level supervision of the programs:

  • Lead the cross-functional teams for the RSV OA vaccine program; potential to lead other early stage vaccine programs as well
  • Represent the program status, scenarios, and trade-offs for RSV vaccine with senior leadership, and internal and external stakeholders
  • Align on a program direction in coordination with senior functional leaders
  • Support development of regulatory documents and HA interactions up to and including BLA submission and VRBPAC
  • Engage external stakeholders including KOLs and key PIs; engage advisory boards in order to develop an effective program strategy
  • Accountable for the integrated development plan for the RSV Older Adult vaccine
  • Develop a program budget in coordination with the program manager, finance and functional representatives; identify trade-offsHere's What You'll Bring to the Table:
    • BS/MS degree in a scientific field with 15+ years of experience or Ph.D or MD with 10-12 years of experience in a biotechnology or pharmaceutical setting
    • Experience in vaccine development including the transition of novel candidates from discovery through licensure
    • Proven track record of successful cross functional program leadership or management supporting early- and late-stage programs
    • Strong ability to lead cross-functional teams; engage senior leadership, health authorities, and KOLs
    • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
    • Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
    • Strong written and oral communication skills as well as demonstrated organizational--aptitude 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-JM1- Posted 15 Days Ago Full time R3997 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 , Sr. Director, Program Leader, Infectious Disease - RSV Older, Executive , Cambridge, Massachusetts

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