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Associate Director, Observational and Collaboration Studies, Infectious Disease

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Mar 23, 2023

View more

Discipline
Science/R&D, Infectious Disease, Pathology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role:

Moderna is seeking an Associate Director to manage programs which will consist of a diverse range of studies within the observational and collaboration franchise for infectious disease. Reporting to the Director, Observational and Collaboration Studies in the Infectious Disease therapeutic area, this position will work collaboratively across Clinical Development, Epidemiology, Global Medical Affairs, and/or Pharmacovigilance supporting assigned studies or programs and team in this area. Clinical study management or project management skills will be used along with knowledge of GxP (GCP and GVP), Good Pharmacoepidemiology Practices (GPP) to lead studies and a team who will manage a diverse set of studies integral to the lifecycle management of Modernas mRNA vaccines and infectious disease therapeutics. The program portfolio of studies includes but is not limited to Post Authorization Safety Studies (PASS), Registry Studies, Epidemiological studies, Real World Effectiveness (RWE) studies, Integrated Evidence studi es and/or other Moderna collaborative or observational studies as assigned. Coordination and collaboration in a face-paced environment are at the center of the role.

Here's What Youll Do:

  • Leads cross-functional operations for global observational research across multiple internal stakeholders, including Clinical Development, Epidemiology, Pharmacovigilance and Medical Affairs

  • Builds and supervises a team focused on assigned observational and collaboration studies, including hiring, coaching and managing the development and performance of staff.

  • Lead or contribute to departmental process or operational initiatives

  • Maintains strong communication channels and partnerships with project Core Teams across all infectious disease franchises, Regulatory, and Pharmacovigilance to ensure appropriate focus and oversight to deliver on global regulatory or risk management plan obligations (e.g., RMP commitments, PASS/PMC, etc).

  • Leads team to establish external partnership and outsourcing strategies and plans, including CRO/ vendor selection, oversight and partnership engagement for observational studies.

  • Partners with Clinical Development and other R&D functions (e.g., Biomarkers, Biostatistics, Quality, Regulatory and Pharmacovigilance) to establish fit for purpose strategies and business practices for the successful and consistent execution of observational and collaboration studies across Infectious Disease.

  • Contribute to activities that support any GCP/GVP audits and regulatory inspections related to study conduct.

  • Reviews or contributes to Clinical Protocol, study plans, manuals, and templates

  • Provides problem-solving expertise to studies and ensures timely creation and execution of study milestones

  • Manage invoice and budget tracking for individual studies and provide input into budget forecasting and accrual activities

  • Manage the cross functional team and CRO/vendor(s) for assigned studies/programs

  • Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures

  • Maintain oversight and participate in the creation/review/maintenance of departmental and organizational SOPs to ensure compliance

  • Develop and maintain strong, collaborative relationships with key stakeholders both within and outside of Moderna

  • Perform and document study level Sponsor Oversight of outsourced clinical activities

  • Communicate study-status, cost and issues to ensure timely decision-making by senior management

  • Provide oversight and mentorship to assigned Project Specialists, Associate Managers, Managers and Senior Managers by providing study and program management expertise

Heres What Youll Bring to the Table:

  • Minimum of BA/BS with at least 8 years study or program management experience. Including at least 4 years of independent study management experience and full drug development life cycle experience (start up, conduct, closure). Advanced degree preferred.

  • Demonstrated experience with direct line management, including hiring and development of junior staff

  • Experience managing non-interventional, observational studies as well as vaccines clinical development is highly desired.

  • Multi-dimensional clinical project management background with demonstrated capability of devising plans, driving timelines and addressing operational challenges.

  • Cross-Collaboration proficiency with other functions such as Biomarkers, Regulatory, CMC, Quality, Pharmacovigilance, Biostatistics/Data Management, Finance and Program Management

  • Experience with FDA, MHRA, EMA and ICH GCP guidelines and or GPP, etc. to ensure the appropriate conduct of studies in the United States, Europe and rest of world

  • Experience in regulatory GCP inspections/audits

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

  • Experience dealing with complexity and ambiguity; ability to collect, digest, and communicate information

  • Excellent ability to manage multiple priorities in a face-paced environment

  • Some travel required

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 year-end shutdown
    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 persons 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.

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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