Key Responsibilities:
- For clinical trials: design, provide oversight, and support site and subject retention
- Ensure successful completion of trial documents (protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, SOPs, etc.) with cross-functional teams
- Participate on study and cross-functional teams as delegated by the Vice President, Clinical Development
- Ensure consistent use of language and criteria across endocrine projects
- Ensure study integrity and track accumulating safety/efficacy data
- Anticipate obstacles in trials and implement solutions
- Analyze, evaluate, and support accurate interpretation and reporting of clinical data
- Draft and review clinical documents, manuscripts, presentations, and regulatory submissions
- Maintain up-to-date knowledge of science, medical information, good clinical practices, and regulatory guidance
- Collaborate with cross-functional colleagues as a clinical research resource to optimize product development
- Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders
- Support corporate strategic and organizational initiatives; assist with commercial activities as needed
- Complete assigned tasks thoroughly, accurately, and on time; adhere to rigorous ethical standards
- Travel up to 20% for scientific meetings
Requirements:
- Advanced degree (Ph.D., Pharm.D., MS, or equivalent)
- Strong track record of scientific and clinical inquiry
- Understand statistical concepts and clinical trial design
- Understand connection between nonclinical and clinical data
- Excellent written and verbal communication; learn quickly and follow complex directions under pressure
- Multi-task, organized, detail-oriented; collaborative and trustworthy; takes initiative and solves problems of moderate complexity
- Sound judgment handling complex confidential regulated information; lead directly and by example
- Preferred (not required): 4+ years clinical trial design/execution; 4+ years pharmaceutical industry; experience with regulatory submissions/interactions
Benefits:
- 401(k) with company match; medical/dental/vision; life and AD&D; short/long-term disability; Pet Insurance; Legal Insurance; Employee Assistance Program; Employee Discounts; Professional Development; HSA/Flexible Spending Accounts; incentive compensation plans; Accident/Critical Illness/Hospital Indemnity; Mental Health resources; paid leave for new parents