Schrödinger seeks an Associate Director / Director of Regulatory Affairs to join our New York early clinical development team. This hire will report to the Director of Regulatory Affairs and will play an essential role in regulatory activities to support activities of global oncology trials in early clinical development.
The Schrödinger regulatory team supports drug development through early clinical proof of concept and is responsible for regulatory strategy and operations. Key deliverables include developing regulatory strategy components of integrated development plans; coordinating interactions with global health authorities to obtain scientific advice; global regulatory submissions (including IND and CTA submissions); safety reporting; and annual regulatory maintenance activities.
Schrödinger applies a proprietary physics-based drug design and optimization platform to the drug discovery process, which expeditiously advances assets into the clinic - making this a dynamic and high-paced work environment.
We are seeking a highly motivated and experienced Associate Director / Director of Regulatory Affairs with expertise in hematology / oncology to join our Drug Discovery and Early Development team. The successful applicant will report to the Director of Regulatory Affairs.
A key competency of this hire will include a demonstrated ability to support global health authority submission for first-in-human oncology studies. The right candidate should be comfortable driving IND preparation, IMPD development; CTR compliant CTA applications (initial submissions and maintenance); managing health authority interactions (such as scientific advice meetings); orphan drug designation (ODD) submissions to the FDA and the EMA; and advising teams on asset strategy; indication strategy; clinical study designs and regulatory plans. Finally, having sufficient working knowledge of regulatory CMC within the EU to support globalization efforts.
- Accountable for developing and implementing innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, EU, Asia-Pacific).
- Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
- Accountable for planning and executing submission strategy for major regulatory dossiers to the FDA and/or EMA.
- Actively participates in regional organizational activities across projects.
- Accountable for conducting regulatory risk planning and mitigation.
- Provides information to support planning and maintenance of the regulatory budget.
- Participates in key interactions with health authorities and communicates health authority feedback to drug discovery and clinical development teams.
- Oversees development and maintenance of internal Global Regulatory Affairs practices and procedures.
- Remains up to date on the global regulatory environment, regulations and guidance (in the NA and EU regions).
- Maintains knowledge of the disease areas through regulatory intelligence and KOL interactions.
- Participates in due diligence activities and alliance management for partnered programs.
- Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may have an impact on the business.
- Develops and maintains strong functional relations with regulatory vendors across multiple regions.
Essential Qualifications and Experience:
- Bachelor's degree; Advanced degree preferred
- A minimum of 5 years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting across multiple regions (NA and EU) .
- Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
- Understanding of EU regulatory principles and their impact on company's development and business goals
- Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas.
- Experience managing regulatory affairs in Hematology/Oncology is required.
- Demonstrated experience in strategic planning, preparing and leading CTA and IND submissions.
- In-depth knowledge of current global regulations and guidance (eg, US, EU, ICH, etc) essential as they relate to the overall global regulatory strategy. Understanding of legal and business aspects related to EU regulatory procedures and outcomes
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Demonstrated ability to anticipate, analyze and resolve complex global regulatory-related problems and lead in situations of uncertainty.
- Domestic and occasional international travel is required.
- Outstanding presentation, data interpretation and communication skills.
- Skilled at working in a multidisciplinary environment.
- Experience managing external teams at CROs including monitoring execution and timely delivery of results.
- Dedicated team-player with in depth understanding of the complexities of cross functional management aspects
- The successful candidate will be a self-starter who is proactive and results-oriented with high performance standards.
- Comfortable working across a number of disease areas and able to shift gears quickly.
- Must be open to change and the unknown with a creative and resourceful spirit.
Pay and perks:
Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, stock options, 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 every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan 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 selected as one of Crain's New York Best Places to Work for the past three years running.
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.