Schrödinger seeks an outstanding Regulatory Chemistry, Manufacturing and Controls (CMC) Director with expertise in early clinical development to join our New York team. This hire will utilize CMC technical knowledge and regulatory science expertise to develop submissions for Schrödinger’s internal portfolio of molecules that are advancing into the clinic. This position will report to the Head of Early Clinical Development and is expected to closely collaborate with CMC and regulatory colleagues to ensure successful submission and maintenance of INDs in support of clinical trials conducted exclusively by Schrödinger.
Our drug discovery and early clinical development team includes a cross-functional group of experts advancing compounds into the clinic. Indications are therapeutically agonistic, but have a strong focus on oncology and inflammation/immunology. The group applies our proprietary physics-based drug design and optimization platform to the drug discovery process, which has successfully advanced ten programs into preclinical development, four programs into clinical development, and one to an FDA approval.
Who will love this job:
- A collaborative team player who can closely interact with multiple functions to create high quality regulatory submissions that support product development strategy.
- An organized project manager/coordinator who can handle multiple projects simultaneously
- An individual who is passionate about ensuring pharmaceutical products are consistently effective, safe and high quality for patients who enroll into our clinical trials.
What you will do:
- Takes a proactive leadership role in the critical review of molecule-specific CMC development strategies and submission content
- Provide regulatory guidance to CMC development teams to ensure teams make well-informed decisions on development or product lifecycle planning
- Develop regulatory strategy and update strategy based upon global regulatory changes
- Lead the preparation, review and finalization of CMC documents for IND submissions
- Oversee and manage outsourced partners, including any CMC regulatory consultants and/or outsourced CMC activities to CRO partners.
- Respond to CMC-related health authority questions
What you should have:
- M.S. degree (PhD preferred) in a science, engineering, or a related field
- A minimum of 8 years of pharmaceutical industry experience
- Five years of regulatory CMC experience supporting early clinical drug development
- Strong understanding of CMC drug development sciences
- Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
- Experience authoring CMC submission content and experience with responding to health authority CMC-related questions
- Experience presenting CMC related issues to the FDA is preferable