[Hiring] Clinical Development Associate Director @SpringWorks Therapeutics
Mar 31, 2025 - SpringWorks Therapeutics is hiring a remote Clinical Development Associate Director. 💸 Salary: $152,000 - $200,000. 📍Location: USA.
Role Description
As the integral member of the study team and program development team, the Clinical Development Associate Director will be responsible for the design and execution of clinical trials within the SpringWorks clinical programs in oncology and rare diseases. In addition, the Clinical Development Associate Director is responsible for the design, preparation, implementation and reporting of clinical study protocols in all phases of development. The Clinical Development Associate Director will work closely with Clinical Operations, Clinical Pharmacology, Data Management, Pharmacovigilance, Field Medical and Biometrics to help manage the clinical trials at SpringWorks.
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
- Design and writing of protocol, CRF, data management plan, statistical analysis plan, and endpoint centric study manuals
- Lead activities 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
- 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
- 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
- Provide 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
- Maintain departmental awareness of scientific information
- Evaluate therapeutic area innovation and competitive landscapes
- Perform other duties and responsibilities as assigned
Qualifications
- Doctoral Degree Required (PhD, PharmD, etc.)
- 7 years clinical trial research experience in pharmaceutical and/or biotechnology industry
- Postgraduate research experience preferred
- Oncology therapeutic area preferred
- 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
- Strong interpersonal communication skills to collaborate effectively in a remote hybrid work environment
- Ability to travel occasionally including overnight stay driven by business need
SpringWorks Leadership Principles
- Change Steward - Recognize that change is essential; set goals that align to the Company’s strategy and create positive momentum for change
- 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
- Community Builder - Establish connections with others to build strong teams that trust each other and collaborate to achieve goals
Compensation and Benefits
The expected salary range for this position is $152,000,000 – $200,000.00. 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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
$152,000 - $200,000
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 31, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
