Senior Director, Clinical Operations - Therapeutics

Company: Moderna Therapeutics Inc.
Location: Cambridge
Posted on: May 23, 2023

Job Description:

The Role:Moderna is seeking a Senior Director, Clinical Operations to manage therapeutics programs across the Therapeutics portfolio with a focus on Rare Diseases. The Senior Director, Clinical Operations, Therapeutics will function as a portfolio lead with oversight of programs and the clinical operations team(s) on those programs. This position will work collaboratively across the therapeutics portfolio and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position will be responsible for initiating and leading clinical programs across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. Additionally, this position will be responsible for management of clinical operations staff which includes but is not limited to talent management, hiring, management and organization of clinical operations teams assigned to programs and studies. This position reports to the Executive Director, Clinical Operations.Here's What You'll Do:

• Serve as a Clinical Operations Portfolio Lead across the Therapeutics, overseeing several programs and the clinical operations team(s) assigned to those programs. These programs may span therapeutic areas such as rare disease, autoimmune, cardiovascular, and other emerging disease areas within Therapeutics. This position will focus on rare disease.
• Accountable for delivery of programs and studies within the assigned portfolio.
• Oversee clinical operations teams and provide direction, oversight and mentorship to ensure the development of operational strategy and plans in support of execution of the Clinical Development Plan.
• Partner and collaborate with cross-functional stakeholders as well as senior leaders at the therapeutic and functional line head level (eg. VP of clinical development, function line heads) to ensure clinical operations effectiveness.
• 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. May serve as the program clinical operations lead (PCOL) for programs in early development until assignment of additional clinical operations resources.
• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations.
• Responsible for budget management for assigned programs/portfolio including ensuring proactive management of all finance activities including but not limited to periodic budget reviews, CRO budget oversight and internal processes related to forecasting at the program and study level.
• Responsible for representing Clinical Operations as a senior leader on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
• Support and supervise the selection, oversight, and management of CROs and other vendors.
• Perform and document study level Sponsor Oversight of outsourced clinical activities as assigned/applicable.
• Oversee program/study team conduct of 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.
• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders.
• Communicate and present to senior leaders on issues, strategies to align, manage and solve issues that arise within the assigned portfolio (program, timelines, budget, other issues as applicable).
• 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.
• Manage clinical operations staff across program and study roles which includes but is not limited to talent management, hiring, management and organization of clinical operations teams assigned to programs and studies.
• 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 12 years of trial and clinical program experience, including 8+ years of high complexity independent, global trial management experience and 4+ years of program-level management Advanced degree preferred.
  • Experience in complex disease areas (e.g., rare disease, autoimmune, cardiovascular and oncology). Rare disease experience required.
  • Robust experience in early and late phase 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 therapeutic areas and 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 requiredModerna 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 ModernaIn 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 .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-TR2-

Keywords: Moderna Therapeutics Inc., Cambridge , Senior Director, Clinical Operations - Therapeutics, Executive , Cambridge, Massachusetts