Early Clinical Development Operations Director

SpringWorks Therapeutics is a commercial-stage biopharmaceutical company dedicated to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

Our diversified targeted oncology pipeline spans solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. Our strategic approach and operational excellence in clinical development have enabled us to rapidly advance our lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for our portfolio and create more solutions for patients with cancer.

The Early Clinical Development Operations Director will oversee the operational aspects of clinical studies on both a portfolio and individual level, 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.

• 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.

• Education: Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline required.
• 10+ years of experience in Clinical Research, with a focus on biotech and/or pharmaceutical Clinical Operations.
• A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP.
• Demonstrated track record in conducting clinical trials in an out-sourced model.
• Experience participating in GCP inspection readiness as part of NDA/MAA activities with an emphasis in ECD.
• Ability to ensure optimal relationships with key internal stakeholders, as well as CSPs, to enable the successful development and deployment of ECD and cross-functional development processes.
• 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.
• Relocation available.

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 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.

• 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.

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

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.

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