About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company’s strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
About the Role:
The Senior Director, Regulatory Affairs role at Springworks is a forward-looking, self-motivator that is excited to be part of a dynamic company focused on the development and ultimate commercialization for patients suffering from severe rare diseases and cancer. The Senior Director will report to Executive Director, Regulatory Affairs and serve as the Global Regulatory Lead to provide global regulatory strategy and leadership on activities in support of SpringWorks targeted therapeutic areas.
This role will be responsible for the development and implementation of global regulatory strategy for a lead asset, ensuring timely preparation, review and submission of Marketing Applications to regulatory authorities globally, and ensuring compliance with applicable regulatory requirements. In addition, this role will be responsible for maintaining any future marketing approvals globally and developing and implementing strategies for indication expansion in collaboration with cross functional program teams.
Key Responsibilities:
- As a seasoned professional in Regulatory, must be able to develop and execute Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies
- Plan and review submissions to global regulatory agencies to support the conduct of clinical trials and approval of marketing applications throughout the lifecycle of assigned projects
- Lead and 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 submission documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
- 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
- Lead and coordinate responses to requests for information from regulatory authorities
- Perform other duties and responsibilities as assigned
Qualifications:
- Experience & Education: 12+ years of Regulatory Affairs related industry experience with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD/PharmD with a 6 years experience; or equivalent work experience.
- Experience in effective negotiations with FDA and EMA.
- Oncology experience preferred, or rare disease 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
- Previous experience in attending and leading a team to prepare for a commercial launch of rare disease products
- Experience with investigational drugs, including late-stage development, and marketed products
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position must be able to work East Coast hours. #LI-Remote
Compensation:
The expected salary range for this position is $202,500.00 - $265,500.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end.
It’s the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group’s (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization’s DNA. SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks’ Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
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
hr@springworkstx.com . 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 hr@springworkstx.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.
