Clinical Business Operations Director

3 weeks ago

Waltham, Massachusetts, United States BioSpace, Inc. Full time
Job Title: Clinical Business Operations Director

The Clinical Business Operations Director will provide strategic leadership and oversight for clinical trial financial management, vendor outsourcing, and budget negotiations. This role will work closely with cross-functional teams to ensure a fit-for-purpose outsourcing strategy and budget management is achieved for each trial.



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


Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.



This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position.



This position may change or assume additional duties at any time.



All Employees are expected to adhere to all company policies and act as a role model for company values.

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