Associate Director, Clinical Study Management
Confirmed live in the last 24 hours
Eikon Therapeutics
Compensation
$183,000 - $199,500/year
Job Description
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.
What You’ll Do
- Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
- Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
- Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions
- Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
- Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
- Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
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