Senior Director, Clinical Operations

Frontier Medicines is seeking a highly motivated individual to fill the position of Sr. Director Clinical Operations to help develop the early project portfolio. The team is focused on the discovery of new medicines to treat cancers and other serious disorders. The successful candidate will play a leading role in progressing our oncology projects through discovery and into clinical development. The position will report to the CMO.

The Sr. Director 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 and work in a highly collaborative and energetic team in a startup environment with short communication lines across functions and departments.

The successful candidate must possess proven leadership experience with a track record of advancing small molecules through various stages of clinical development.

Requirements

What will you be doing?

• Partner with team leader to ensure expectations, deliverables and timelines are aligned across the team
• Provide operational expertise and strategic input on the development of Clinical Development Plans (CDP) including managing the timelines, supporting the clinical strategy for one or more clinical programs
• Provide program and study-level direction to the strategic partners/preferred suppliers to develop study strategy operational plans including enrolment models and risk management strategy
• Ensure assessment of multiple development scenarios including risks, mitigation, timelines and budgets for the strategic execution of the CDP
• Partner with key stakeholders (internal and external) to develop high-quality study synopsis/protocol by providing operational/project management input and by ensuring all relevant partners are involved and contributing

• Perform program-level oversight of strategic partners and other vendors to ensure the operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations) and on budget

• Create and maintain integrated project timelines and prepares internal team documents in partnership with team leader and other key stakeholders

• 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
• Work closely with collaborators and external stakeholders to form a strong strategic alliance and advance company goals

Traits we believe make a strong candidate:

• BS in Life Sciences, Physical sciences or relevant discipline +15 yrs pharma/biotech experience in Clinical Operations and Project Management; must have minimum 5 yrs Oncology development experience
• MS or PhD degree in Life Sciences, Physical sciences or relevant discipline +10 yr pharma/biotech experience in Clinical Operations and Project Management ; must have minimum 5 yrs 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 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.