Early Clinical Development Operations Director

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.

Your Role :

The Early Clinical Development (ECD) Operations Director will oversee the operational aspects of clinical studies on both a portfolio and individual level and is responsible for all functional operations of ECD. As the operational lead for individual studies, the ECD Operations Director will serve as the primary point of contact for contract service providers (CSPs) involved in all study aspects and will independently work cross functionally for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. On a portfolio level, in collaboration with the head of Early Clinical Development / Clinical Pharmacology, the ECD Operations Director will support / execute the development of early development plans and strategy by sponsoring and / or leading key strategic ECD Operations organizational initiatives.

Location Classification - Hybrid :

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Location Classification - Remote :

Officially classified as working full-time from employee's home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs.

Essential Duties and Responsibilities :

• Lead key strategic ECD Operations' organizational initiatives, including the identification of process challenges, process enhancements, and training within in the ECD Operations organization, if applicable.
• Lead study design, execution, and reporting of clinical pharmacology / poof-of-concept studies. Provide input into all phases of drug development including, but not limited to proof-of-concept, dose finding, dose optimization, exposure-response, and pediatric development.
• Lead development of clinical pharmacology sections for study design, protocol development, study execution, reporting, interpretation of data, regulatory filings including annual reports, investigator's brochure, and IND / NDA applications.
• Manage CSPs to execute clinical trials in accordance with contracted scope, costs, and timelines; actively engage with CSPs on defining, monitoring, and reporting on aspects of key trial performance indicators (e.g., country and site initiation activities, participant screening and randomization rates, and data collection activities).
• Author, review and / or manage a wide variety of activities, including for example, clinical study synopses and study protocols, informed consent forms, case report forms, study reference manuals, monitoring plans, data management plans, site initiation visit meeting presentations, etc.
• Direct internal teams to ensure database lock activities occur in a timely manner, coordinate activities for delivery of top-line data, as necessary, and review and approve clinical study reports in accordance with overall project timelines.
• Identify risks to clinical study execution success, proactively communicate risks to internal and CSP teams, and bring teams together to develop and implement risk mitigation strategies and tactics to enable trials to complete as planned.
• Collaborate with internal and external scientific and medical experts to plan and execute studies that support and / or develop ECD strategies and plans.
• Develop or contribute to the development of SOPs, workflows and / or business practices, and oversee training requirements / compliance and financial forecasting for projects and staffing plans.
• Lead the creation, deployment, and management of ECD Operations' process and procedures, GCP compliance, and regulatory inspection-readiness activities.
• Perform other duties and responsibilities as assigned

Role Requirements :

SpringWorks Leadership Principles :

Compensation & Benefits :

The expected salary range for this position is $167,250.00 - $220,000.00. 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 offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

DE&I : We believe in fostering a culture of belonging. Explore how we are committed to DE&I

EEO Statement :

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.

Privacy : Upon submission of this form I understand that SpringWorks Therapeutics is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S.. Information about SpringWorks Therapeutics' privacy practices can be found at Privacy Policy - Springworks (springworkstx.com).

Salary : $167,250 - $220,000