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Associate Director, Clinical Operations, Oncology – Moderna – Cambridge, MA

The Role:

Moderna is seeking an Associate Director of Clinical Operations to manage programs within the Oncology Therapeutic Area, which may consist of managing one or more studies. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.

Here’s What You’ll Do:

  • Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

  • Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan

  • Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders

  • Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs

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

  • Support the selection, oversight, and management of CROs and other vendors

  • Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

  • Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

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

  • Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders

  • 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

  • Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs

  • Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

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

  • Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

  • Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna

  • Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations

  • Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise

  • Strive for continuous improvement and more efficient ways of working in clinical development

  • Act as a role model for Moderna’s values

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

  • Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred.

  • Robust experience in immuno-oncology required. Experience in hematologic malignancies desirable but not required.

  • Robust experience in early and late phase global drug development

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

  • Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

  • Experience in GCP inspections/audits

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

  • Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

  • Resilient, Creative, capable problem-solver

  • Excellent organizational skills and ability to work independently

  • Experience in establishing and maintaining relationships with key opinion leaders

  • Some travel required

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.

Source: Indeed.com
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