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.

The position:

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.

Responsibilities:

• 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.

Desirable Skills:

• 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.