Career Opportunities in the Foresite Capital Network

The Opportunity:

• Reporting to the Chief Medical Officer, you will join our Precision Medicine leadership team and guide the company’s regulatory strategy and operations.
• You will be accountable for developing and implementing the regulatory strategy and submissions required to progress our product candidates from non-clinical development through clinical development and registration.
• You will be responsible for coaching and mentoring our regulatory strategy and operations staff to support their growth and development.

Your Role:

• You will work side by side with our Chief Medical Officer and your clinical development colleagues to develop regulatory strategies for various development programs (from FIH through late-stage clinical trials).We will lean on you to lead the development and implementation of non-clinical and clinical regulatory strategy for projects in all stages of development.
• You will develop briefing packages, expedited program applications, orphan drug applications for meetings with FDA and other global health authorities.
• You will provide regulatory leadership and guidance to regulatory staff and project teams for the development of domestic and global regulatory submission documents.
• You will oversee the development of response strategies and submissions to regulators.
• You will integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
• You will ensure clinical and nonclinical programs are designed and implemented to meet regulatory requirements.
• You will be accountable for compliance with regulatory filing and reporting requirements.
• .You will attend and lead critical health authority meetings.
• We will depend on you to stay up to date on global regulatory changes that may impact asset development and keep us informed.

Your Background:

• You have earned your B.S and/or M.S. and bring 10+ years of relevant work experience in pharmaceutical regulatory affairs.
• You have advanced knowledge and experience in global oncology and non-oncology drug development and regulatory strategy. You have experience interfacing with relevant regulatory authorities -you have experience successfully filing and managing IND, CTA and NDA/MAA submissions. Experience in precision oncology strategy​ and companion diagnostic (CDx) development is a plus.
• You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements, and know how best to exercise regulatory flexibility.
• You are a strategic thinker; you can propose innovative solutions to regulatory problems to ensure the efficiency and effectiveness of major regulatory submission processes.
• You have excellent written and verbal communication skills, a candid and articulate communicator, you can flex to different work styles, and believe that the best outcomes result from using the strengths of your team members.
• You have a "can do" attitude, and you are passionate about the impact of regulatory work on patients.
• You will be a coach and mentor to our junior staff to support their growth and development and you are passionate about empowering your team to shine.