Manager / Sr. Manager, Clinical Operations at SpringWorks Therapeutics

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.

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 are in it together.  We are looking for ambitious, smart, and hardworking colleagues to join our growing team. 

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?

Does this sound like fun?

About the Role:

Responsible for the overall day-to-day operational management and the oversight of clinical trials. Works closely with the clinical and/or medical affairs operation and development teams to provide oversight of Clinical Contract Service Providers (CCSPs) and other third-party vendors. The main responsibility is to work with cross-functional team members for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables.  Manager/Sr. Manager must facilitate effective internal and external relationships.

Role and Responsibilities:

Study set-up: 

• Assist with identification, evaluation, and selection of appropriate CCSPs and third-party study vendors 
• Assist will generation/tracking Request For Proposals (RFPs), and detailed assessment of CCSP/vendor bids and proposals 
• Assist with contracting process (MSAs, SOWs, etc.) 
• Assist with study design and timelines as required
• Assists or leads development of clinical protocols, amendments, informed consents forms, study guides, case reports forms, edit specifications, study manuals, and any other clinical research related documents 

• Assist with coordinating study drug supplies and projections at study start 
• Assist with reviewing/negotiating site budgets and liaise with SpringWorks legal and CCSP regarding Clinical Trial Agreements (CTAs)    
• Participate in setting up investigator meetings with the CCSP as needed 
• Oversee study start-up process and report on study start-up metrics provided by the CCSP
• Attend Site Initiation Visits (SIVs) with the CCSP CRAs as appropriate  

Study maintenance: 

• Foster good working relationships with CCSPs/vendors, investigators, site personnel, etc. 
• Provide ongoing training and support to CCSP CRAs 
• May work with CCSP to develop and revise scope of service agreements, budgets, plans and detailed timelines as needed throughout the studies 
• Review site study documents (informed consent revisions, and study tools/worksheets) 

• Manage interim data analyses if applicable 
• Review/approve monitoring visit reports and identify/report and quality issues 
• Review vendor passthrough costs as invoiced 
• Assist with ongoing budget management with vendors 
• Interface with clinical supply manager for management of study drug/supplies 
• Study close-out:
• Work with CCSPs to develop efficient site/study closure plans 
• Ensure all study documents are transferred from the CCSP to SpringWorks’ electronic Trial Master File (eTMF) at the end of the study 
• Close-down CCSP/vendor contracts, etc. 
• Contribute to Clinical Study Report (CSR) writing and New Drug Application (NDA) submissions as applicable 

Qualifications and Educational Requirements:

Bachelor’s level degree in life sciences or related field with 5+ years in global/regional clinical drug development or in the Pharmaceutical/Biotech industry. 

Preferred Skills/Licenses:

• Excellent written and verbal communication skills
• Excellent team player and able to build an effective team without senior management oversight
• Must be able to interact and liaison effectively with people at all levels of the organization and with external vendors, investigators, site personnel, etc. 
• Good working knowledge of GCP and ICH 
• Detail-oriented and well organized 
• Understanding of steps required to set up and successfully manage delivery of Phase 1-4 studies 
• Solid computer/analytical skills 
• Proficient in Microsoft Word, Excel, and PowerPoint 

Other Skills / Attributes:

• Adaptable 
• Nimble 
• Accountable 
• Highly motivated self-starter 
• Independent

Employment Specifics:

Organization                              SpringWorks Therapeutics

Employee Status                       Regular Full -Time                                

Benefits                                    Competitive compensation and benefits package

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