Clinical Development Associate Director

Summary

Join SpringWorks Therapeutics as a Clinical Development Associate Director and play an integral role in designing and executing clinical trials for oncology and rare diseases. You will lead various aspects of clinical study development, from protocol design to data analysis and reporting. Collaborate closely with cross-functional teams, including Clinical Operations, Data Management, and Medical Affairs. This remote position requires a doctoral degree (PhD, PharmD, etc.) and 7+ years of clinical trial research experience in the pharmaceutical or biotechnology industry. Relocation assistance is available. SpringWorks offers a competitive salary and comprehensive benefits package.

Requirements

• Doctoral Degree Required (PhD, PharmD, etc.)
• 7 years clinical trial research experience in pharmaceutical and/or biotechnology industry
• Ability to lead, influence and shape scientific planning, conduct and analysis in alignment with the applicable program strategy
• Well versed in critical review of scientific information with good working knowledge of GCP and ICH guidelines
• Understanding of steps required to set up and successfully manage delivery of all phases of studies
• Excellent interpersonal skills with proven high performance in a study and program team matrix
• 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

Responsibilities

• Design and writing of protocol, CRF, data management plan, statistical analysis plan, and endpoint centric study manuals
• Lead the following activities in the areas related to the Clinical Scientist’s expertise (e.g., response evaluation, biomarker assessment, imaging, etc.) Selection and management of clinical study support vendors and clinical study sites with respect to functional capabilities related to pertinent endpoints and study procedures
• Engagement and education of investigators (e.g., Investigators’ Meeting, Site Initiation Visit, data reviews)
• Lead data querying during the clinical trial conduct and support external data reconciliation (Biomarkers, Imaging, etc.)
• In collaboration with Data Management and Medical Monitor, prepare the data review plan and perform data reviews using patient profiles or other reporting formats and tools
• Assessment of reported protocol deviations and trends and potential study impact
• Preparation and conduct of meetings to review clinical trial results (e.g., cohort review, DMC, Steering Committee)
• Analysis and interpretation of clinical trial results and trends including preparation of the clinical study report and associated abstracts and/or publications
• Providing guidance and input to the following documents in the areas related to expertise (e.g., response evaluation, biomarker, or imaging strategy): Investigator’s Brochure
• Clinical Development Plan, with particular emphasis on the Biomarker and Imaging strategy and analysis plan
• Regulatory submissions
• Publication strategy and plan for the program or therapeutic area
• Individual publications and other scientific/clinical information aligned with the overall program strategy
• Ensure consistent practices in the conduct and management of scientific approaches across trials and programs, as needed
• Maintain their own and departmental awareness of scientific information
• Evaluate therapeutic area innovation and competitive landscapes
• Perform other duties and responsibilities as assigned

Preferred Qualifications

• Postgraduate research experience
• Oncology therapeutic area

Benefits

• Relocation assistance available
• The expected salary range for this position is $152,000,000 – $200,000.00
• 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