Sr. Director, Clinical Operations, Coronavirus Programs

Location
Cambridge, MA
Posted
Jun 14, 2022
Ref
R8412
Required Education
Bachelors Degree
Position Type
Full time

The Role:

Moderna is seeking a Sr. Director of Clinical Operations to lead our Coronavirus program clinical operations team.  Reporting directly to the VP, Clinical Operations, Infectious Disease, this position will work collaboratively with the broader Coronavirus Program Core Team and all cross-functional areas to deliver on the execution of global clinical studies.  Responsibilities include direct line management of staff to ensure clinical studies are conducted in accordance with their respective study protocols, Moderna SOPs, ICH GCP and other applicable local regulations.  As a senior leader, this role serves as a key escalation point for study teams and CRO/vendors and is expected to be both strategic and tactical (i.e., “hands on”) to solve complex study challenges.  The Senior Director will play an integral role in shaping the culture in the Infectious Disease Clinical Operations team, which includes leading and championing the implementation of novel tools and initiatives as Moderna expands its capabilities to support a growing mRNA vaccine portfolio.   

Here’s What You’ll Do:

  • Builds and supervises the Coronavirus Clinical Operations teams, including hiring, coaching and managing the development and performance of staff.

  • Guide Program Clin Ops Leads (PCOL) and study Clinical Ops Leads (COL) to achieve successful execution of global clinical studies to a high standard of quality (i.e., ICH – GCP), within budget and timelines.

  • Deploys Clinical Operations resources for each new study, including reallocation of resources based on emergent information or shifting priorities.

  • Actively participates as part of the Infectious Disease Clinical Operations Leadership Team by contributing to the development and implementation of functional initiatives, resourcing strategies and evolution of the organizational structure to meet departmental needs.

  • Support global clinical outsourcing strategies and plans, including CRO/ vendor selection, oversight and partnership engagement.

  • Responsible for representing Clinical Operations on cross-functional leadership / governance teams internally and with relevant external stakeholders (e.g., Vendor/CROs, government or funding collaborators and investigators) regarding Coronavirus vaccines programs.

  • Along with other Clinical Development personnel, represent Moderna externally (e.g., to Investigators/trial site administrators, industry forums, etc.).

  • Oversee/collaborate on and contribute to activities that support any GCP audits and regulatory inspections related to clinical trial conduct.

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

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

                                                            

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

  • At least 10 years of global trial management experience in a clinical research environment, most of which should be in industry. Infectious Disease and Vaccines experience is highly preferred.

  • Advanced degree preferred, with at least a Bachelor’s in a science-based discipline.

  • Demonstrated experience managing and developing clinical operations personnel at multiple levels.

  • Substantial experience in all phases of vaccine/drug development and proven track record of success in late phase, pivotal studies.

  • Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, site/program budget negotiations, etc.

  • Excellent team building and collaboration skills, for both the Coronavirus team and the organization as a whole.

  • Proficient cross-collaborating with other internal and external functions within development such as also Regulatory, Pharmacovigilance, Quality Assurance, Finance, etc.

  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world with past experience in regulatory GCP inspections/audits

  • Outstanding verbal and written communication skills for clinical authoring experience including protocols, investigator brochures, etc.

  • Excellent organizational and multi-tasking ability skills and the ability to work independently in a self-driven manner, including the resilience to quickly pivot with changing priorities.

  • Proven track record of effective leadership, including achieving results through others, in the context of a multi-disciplinary team in the biotech or pharmaceutical industry.

  • Creative, capable problem-solver who can rapidly flex to being “hands on” when required.

  • Experience in establishing and maintaining relationships with key opinion leaders.

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.

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