We’re seeking an Associate Director of Regulatory Affairs with expertise in hematology and oncologyto join our Early Clinical Development team in New York or Cambridge, MA. This hire will report to the Director of Regulatory Affairs and will play an essential role in the regulatory activities of global oncology trials in early clinical development.
Our Drug Discovery and Early Clinical Development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Several programs we have worked on have achieved development candidates, including progression to clinical development and FDA approval. You can view our entire pipeline of wholly-owned programs and collaborations here.
What you’ll do:
- Develop and implement innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, EU, Asia-Pacific)
- Plan and execute submission strategy for major regulatory dossiers to the FDA and/or EMA
- Integrate the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives
- Actively participate in regional organizational activities across projects
- Conduct regulatory risk planning and mitigation
- Provide information to support planning and maintenance of the regulatory budget
- Participate in key interactions with health authorities and communicate health authority feedback to drug discovery and clinical development teams
- Oversee development and maintenance of internal global regulatory affairs practices and procedures
- Remain up to date on the global regulatory environment, regulations and guidance
- Maintain knowledge of the disease areas through regulatory intelligence and KOL interactions
- Participate in due diligence activities and alliance management for partnered programs
- Watch, anticipate, and act on trends and changes in the international regulatory environment which may have an impact on the business
- Develop and maintain strong functional relations with regulatory vendors across multiple regions
Essential Qualifications and Experience:
- Bachelor’s degree; advanced degree preferred
- A minimum of ten years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting across multiple regions
- Expert understanding of policy, laws, regulations, and guidelines as they apply to the US FDA for drug development and approval
- Understanding of EU regulatory principles and their impact on the company’s development and business goals
- Experience managing regulatory affairs in hematology/oncology
- Demonstrated experience in strategic planning, preparing, and leading CTA and IND submissions
- In-depth knowledge of current global regulations and guidance as they relate to the overall global regulatory strategy
- Excellent organizational, writing, and time management skills to manage multiple ongoing projects simultaneously
- Demonstrated ability to anticipate, analyze and resolve complex global regulatory-related problems and lead in situations of uncertainty
- Willingness to travel
- Outstanding presentation, data interpretation and communication skills
Pay and perks:
Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, equity-based compensation, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Office Management team also plans a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been included in Crain’s New York Best Places to Work, BuiltIn’s NYC Best Place to Work, and Newsweek’s list of America’s 100 Most Loved Workplaces.
Estimated base salary range: $170,000 - $215,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company’s mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, "diversity" isn’t just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn’t mean better headlines or public images - it means increased adaptability and profitability.
