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Clinical Business Operations Director

1 month ago

Waltham, Massachusetts, United States BioSpace, Inc. Full time
Job Summary

The Associate Director, Clinical Business Operations provides strategic support for vendor outsourcing and financial oversight for Dyne's clinical trials. This role is responsible for ensuring efficient, accurate clinical trial financial management, including forecasting, reporting, and oversight of vendor spend.

This role assists with contract and budget negotiations for multiple clinical trial vendors and services across multiple clinical studies. They collaborate on the identification, development, and implementation of cost management tools, processes, and efficiencies across clinical programs to optimize spend within Clinical Operations.

The Associate Director, Clinical Business Operations works closely with cross-functional teams to ensure a fit-for-purpose outsourcing strategy and budget management is achieved for each trial.

This role will work closely with other internal stakeholders, including Finance, Legal, and Quality.

Key Responsibilities:

  • Lead and manage the operational aspects of clinical business operations, including overseeing clinical trial budgets, vendor selection, and relationship management.
  • Develop and implement strategic plans to optimize clinical business operations and ensure the efficient and cost-effective execution of clinical trials.
  • Collaborate with cross-functional teams, including clinical development, regulatory affairs, and finance, to align on trial execution plans and milestones.
  • Manage relationships with external vendors, CROs, and other partners to ensure high-quality deliverables, adherence to timelines, and budget management.
  • Oversee the development and management of clinical trial budgets, forecasting expenses, and tracking financial performance against forecast.
  • Ensure compliance with regulatory requirements, GCP guidelines, and company SOPs in all aspects of clinical business operations.
  • Provide leadership and mentorship to team members, fostering a culture of collaboration, continuous improvement, and excellence in clinical business operations.
  • Develop, implement, and maintain financial planning tools and models focused on clinical trial spend, forecasting, and long-term planning.
  • Lead initiatives and projects related to clinical financial planning and management, ensuring solutions are scalable.
  • Create and maintain dashboards and monthly financial reports for a cross-functional audience.
  • Provide support of the Request for Information (RFI) and/or Proposal (RFP) process for Development programs and/or clinical studies of various phases, complexity, and risk.
  • Manage contract and financial negotiations with external service providers for Development programs.
  • Partner with the Legal to ensure that the appropriate templates and legal terms/conditions are applied.
  • Maintain current knowledge of outsourcing industry trends and provide ongoing support and training to key stakeholders on best outsourcing practices.
  • Proactively identify and collaborate to address opportunities for process or business improvements, including operational efficiencies.
  • Embrace and enable diversity of perspectives to enhance the overall effectiveness of the team.
  • Represent Clinical Operations and support other functions on company-wide process improvements and initiatives.
  • Travel up to 25% domestic and/or international.

Requirements:

  • Bachelor's degree; advanced degree (e.g., MBA, MPH) preferred.
  • At least 8 years of experience working within a pharmaceutical/biotech company, CRO, or similar organization.
  • At least 5 years of experience in clinical trial finance management (tracking, forecasting, and reporting).
  • Experience developing/using financial tracking and forecasting tools for clinical trials.
  • Demonstrated leadership and project management skills, with a track record of successfully leading cross-functional teams and delivering results on time and within budget.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate and establish effective business relationships with internal and external stakeholders at all levels.
  • Experience in outsourcing management, vendor budget negotiations, budget management, and vendor oversight.
  • Experience in developing and implementing process improvements and operational efficiencies in clinical business operations.
  • Experience as a strategic partner providing effective and complex solutions and systems to the organization.
  • Comprehensive understanding of clinical trial operations regulatory requirements, with an understanding of clinical trial operations.
  • Strong analytical, negotiating, and business communication skills.
  • Ability to think strategically and effectively communicate ideas.
  • Able to interact and influence effectively with multi-functional teams at all levels of the organization.
  • Self-motivated and able to prioritize and manage a large volume of work in a dynamic, changing, growing start-up culture.

About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.

With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue.

Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

What We Offer

Dyne Therapeutics offers a dynamic and collaborative work environment, with opportunities for professional growth and development.

We are committed to diversity, equity, and inclusion, and strive to create a workplace that is welcoming and inclusive for all employees.

How to Apply

If you are a motivated and experienced professional looking to join a dynamic team, please submit your application, including your resume and a cover letter, to [insert contact information].