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Senior Director of Clinical Operations

1 month ago


South San Francisco, California, United States Frontier Medicines Full time
Job Title: Senior Director, Clinical Operations

Frontier Medicines is seeking a highly experienced Senior Director of Clinical Operations to lead the development of our early project portfolio. As a key member of our team, you will play a critical role in progressing our oncology projects through discovery and into clinical development.

The successful candidate will have a proven track record of advancing small molecules through various stages of clinical development and will be responsible for providing operational expertise and strategic input on the development of Clinical Development Plans (CDPs). This includes managing timelines, supporting clinical strategy, and ensuring the assessment of multiple development scenarios.

We are looking for a leader who can partner with key stakeholders to develop high-quality study synopses/protocols and perform program-level oversight of strategic partners and vendors to ensure the operational execution and delivery of assigned clinical programs. The ideal candidate will have expertise in global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP.

The Senior Director of Clinical Operations will be a key contributor to Frontier Medicines' success and will be interacting with senior leaders, including the CEO, routinely. This is an opportunity to join a highly collaborative and energetic team in a startup environment with short communication lines across functions and departments.

Responsibilities:

  • Partner with team leaders to ensure expectations, deliverables, and timelines are aligned across the team.
  • Provide operational expertise and strategic input on the development of Clinical Development Plans (CDPs).
  • Manage timelines, support clinical strategy, and ensure the assessment of multiple development scenarios.
  • Partner with key stakeholders to develop high-quality study synopses/protocols.
  • Perform program-level oversight of strategic partners and vendors to ensure operational execution and delivery of assigned clinical programs.
  • Ensure assessment of multiple development scenarios, including risks, mitigation, timelines, and budgets.
  • Lead creation of team practices and operating principles with a focus on cross-functional input and accountability.
  • Act as an integrator within the Project Team, across the enterprise, and with external partners to ensure alignment and connect best practices.
  • Develop and coordinate resource planning to assure adequate resources are applied to the project.
  • Coach project team members and others to drive excellence and accountability.
  • Embody a culture of improvement and progress; promote knowledge sharing.

Requirements:

  • BS in Life Sciences, Physical sciences, or relevant discipline + 15 years of pharma/biotech experience in Clinical Operations and Project Management; must have minimum 5 years of Oncology development experience.
  • MS or PhD degree in Life Sciences, Physical sciences, or relevant discipline + 10 years of pharma/biotech experience in Clinical Operations and Project Management; must have minimum 5 years of Oncology development experience.
  • Expertise in global regulatory and compliance requirements for clinical development, including but not limited to: US CFR, EU CTD, and ICH GCP.
  • Breadth of scientific expertise with solid understanding of project strategy and disease content to contribute to strategic discussions.
  • Leadership skills, including situational leadership and ability to influence without authority.
  • Embody a culture of improvement and progress; promote knowledge sharing.
  • Strong communicator able to integrate and succinctly summarize the various parts of a project and effectively tailor messages to audience incl. senior leaders.
  • Ability to resolve complex problems and manage difficult stakeholder situations.
  • Proven excellence in clinical operations and project management - drives execution while balancing speed, quality, and cost.
  • Legally authorized to work in the US.

Benefits:

  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan (401k, IRA)
  • Life Insurance (Basic, Voluntary & AD&D)
  • Paid Time Off (Vacation, Sick & Public Holidays)
  • Family Leave (Maternity, Paternity)
  • Short Term & Long Term Disability
  • Training & Development
  • Free Food & Snacks
  • Wellness Resources
  • Stock Option Plan

At Frontier Medicines, we strive to build a diverse and equitable workplace. The salary range for this role is $211,500 – $285,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies, and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k, and a broad range of other benefits.

This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.