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 CMC Operations Director works closely with the SVP, Head of CMC and the departmental leadership team to establish strategic plans and corresponding budget, define objectives and key results, and ensure targets are delivered on time. Responsibilities include developing, managing and tracking integrated program plans and timelines for the CMC Team, developing end-to-end project plans that detail critical milestones, budgets, resources, timing, and roles and responsibilities. This individual will manage the financial operations of the CMC Team, which will include budget oversite, review of contracts, creation of purchase orders, invoice tracking and working with the finance department to support month end closure and other budget related activities. In addition, this individual will support CMC regulatory submissions by coordinating and tracking submissions and amendments as well as contributing to the authoring of regulatory documents as needed. This individual will work with cross-functional teams across R&D, finance and legal to promote a culture of collaboration and accountability through outstanding organizational & leaderships skills.
Responsibilities Include:
- Lead operational execution of CMC Team and ensure optimal delivery of objectives and key results.
- Develop integrated program plans and timelines for CMC Team.
- Manage financial operation of CMC Team.
- Coordinate and contribute to CMC regulatory submissions.
- Work cross-functionally across R&D, finance and legal to promote a culture of collaboration and accountability.
- Author departmental SOP and Policies as required.
- Support the forecasting and budgeting process.
- Engage with internal and external partners to seek insights, best practices and identify innovations from experts.
- Ensures timely execution of critical tasks, milestones and deadlines.
- Perform other duties and responsibilities as assigned.
About You: Required Education, Skills, and Experience
- Education: Bachelors degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field is required
- 15+ years broad industry experience in product development, project management and technical operations
- Demonstrated scientific knowledge of the drug development process, including manufacturing and testing of drug substance and drug product
- Strong analytical problem-solving and strategic thinking skills
- Proficient in use of project management tools and relevant software
- Interacts and collaborates at all levels, including effective interfacing at the senior management level
- Ability to negotiate, resolve conflicts, prioritize, organize, and influence decision making of stakeholders
- Must be able to perform in fast paced environment, exhibit leadership skills, and influence without authority
- Strong written and oral communication skills
- Demonstrated ability to translate and present complex information to others effectively
- Strong project and financial management experience
- Self-starter capable of working independently
- This position must be able to work East Coast hours
- Ability to travel occasionally (>15%)
Preferred Education, Skills, and Experience
- Education: Advanced Degree preferred (Master/Ph.D/etc.)
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.
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