About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.
About the Role:
The Clinical Regulatory Affairs Director role at SpringWorks is a self-motivator that is excited to be part of a dynamic team that is focused on the development and ultimate commercialization for patients suffering from severe rare diseases and cancer.
The Director will report to the Head of Regulatory Affairs to support regulatory activities in for, nirogacestat that is in Phase 3 for desmoid tumors, including our pipeline programs. This position will have oversight for IND maintenance activities, DSUR review, CTA submissions and working with our external CRO for outside U.S. filings. This includes the implementation of regulatory strategy, ensuring timely preparation, review, and submission of documents to regulatory authorities, and ensuring compliance with applicable regulatory requirements.
- Represent the regulatory function on cross-functional development teams.
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies.
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects.
- Oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
- Under the guidance of the Head of Regulatory Affairs, serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and advise the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings.
- Supervise, analyze, and disseminate intelligence on matters that may affect ongoing development programs.
- Provide interpretation of and advice regarding regulations, directives, and guidance.
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and collaborate with regulatory authorities; be primary liaison for day-to-day interactions.
- Coordinate responses to requests for information from regulatory authorities.
- Work externally to engage in regulatory policy initiatives.
- Perform other duties and responsibilities as assigned.
About You: Required Education, Skills, and Experience
- Education: Advanced degree in scientific discipline or related field
- 9+ years of Regulatory Affairs related industry experience
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g., FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- Knowledge and understanding of global regulations and guidelines
- Experience with investigational drugs, including late-stage development, and marketed products
- Previous experience in attending and leading a team to prepare for a commercial launch of rare disease products
- Experience influencing key stakeholders and driving decisions in a matrixed environment
- Ability to work in a cross-functional team environment with experience managing people and project teams
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Excellent verbal and written communication skills and interpersonal skills are required
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- This position must be able to work East Coast hours
- Ability to travel occasionally (>15%)
Are you a SpringWorker?
How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?
At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we’re in it together. We are looking for ambitious, smart, and hardworking colleagues to join our growing team.
SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics (“Controller”), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing firstname.lastname@example.org . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at email@example.com.
Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.