We are seeking a Director of Regulatory Affairs to join us in our mission to discover and develop drugs that improve human health through the use of breakthrough computational methods. We are seeking outstanding individuals to join our drug discovery group and contribute to our rapidly expanding portfolio of drug discovery programs and collaborations.
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. Ten of the programs we’ve worked on with collaborators have progressed into preclinical development with four currently in clinical trials.
We are seeking a highly motivated and experienced 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 Head of Early Clinical Development.
A key competency of this hire will include a demonstrated ability to develop regulatory strategy for early development compounds through the application of scientific and clinical knowledge.
The right candidate should be comfortable driving IND preparations, managing health authority interactions (such as pre-IND meetings), and advising teams on asset strategy, indication strategy, clinical study designs and regulatory plans. Finally, having sufficient working knowledge of regulatory CMC and regulatory operations to oversee regulatory CMC outsourcing and regulatory operations outsourcing is desired.
- Accountable for developing and implementing innovative global regulatory strategies to maximize the likelihood of regulatory success.
- Accountable for planning and execution of submission strategy for major regulatory dossiers.
- 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.
- Maintains knowledge of the disease areas through regulatory intelligence and KOL interactions.
- Participates in due diligence activities and alliance management for partnered programs.
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.
- Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
- 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 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.
- 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.
- 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.