Clinical Operations Director
4 days ago
We are seeking a highly skilled Associate Director, Clinical Operations to join our team and contribute to the development of innovative oncology projects. As a key member of our clinical operations department, you will play a crucial role in progressing our early project portfolio through discovery and into clinical development.
About UsAt Frontier Medicines, we strive to build a diverse and equitable workplace where everyone has the opportunity to thrive. Our team is dedicated to discovering new medicines to treat cancers and other serious disorders.
Salary and BenefitsThe salary range for this role is $150,000 - $190,000, depending on your qualifications, skills, and experience. Our total rewards package includes comprehensive health care coverage, a retirement plan, life insurance, paid time off, family leave, short-term and long-term disability, training and development opportunities, free food and snacks, wellness resources, and a stock option plan.
Job DescriptionThis is an exciting opportunity to work in a collaborative and energetic startup environment with short communication lines across functions and departments. You will have the chance to interact with senior leaders, including our CEO, and contribute to strategic discussions. Your expertise in global regulatory and compliance requirements will be invaluable in managing clinical studies and ensuring that our projects meet the highest quality standards.
Main Responsibilities:- Partner with the 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 (CDPs) including managing timelines, supporting clinical strategy for one or more clinical programs.
- Lead program-level oversight of strategic partners and vendors to ensure operational execution and delivery of assigned clinical programs in compliance with quality standards and on budget.
To succeed in this role, you must have a strong track record of advancing small molecules through various stages of clinical development. Your leadership skills should include situational leadership and the ability to influence without authority. You should embody a culture of improvement and progress, promoting knowledge sharing and collaboration within the team.
Qualifications:- Bachelor's degree in Life Sciences, Physical Sciences, or a relevant discipline + 8 years' pharma/biotech experience in Clinical Operations and Project Management; minimum 5 years' oncology development experience required.
- Master's or PhD degree in Life Sciences, Physical Sciences, or a relevant discipline + 10 years' pharma/biotech experience in Clinical Operations and Project Management; minimum 5 years' oncology development experience required.
- Expertise in global regulatory and compliance requirements for clinical development, including US CFR, EU CTD, and ICH GCP.
- Must have sponsor experience managing clinical studies.
- Breadth of scientific expertise with solid understanding of project strategy and disease content to contribute to strategic discussions.
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