Clinical Science Associate Director
- Ph.D or Pharm.D. preferred. Other education with experience considered.
- Immunology clinical experience required; Oncology experience preferred
- 4+ years in a clinical position in the pharmaceutical industry with deep knowledge of all phases the clinical development process
- Pre-IND, translational, IND submission to Phase 1 experience preferred
- Experience with biologics preferred
- Proficient in medical writing (e.g protocols, IBs)
- Experience in data interpretation and analysis and use of software to do so (e.g. pivot tables, Spotfire, or Medidata, etc)
- Excellent ability to understand and pick up clinical science / research from a medical, regulatory, and marketing perspective
- Maturity in terms of interactions with others internally and externally and maintaining confidential information.
- Proficiency in medical communications via writing and presentations
- Write and edit clinical materials such as protocols, the clinical part of regulatory submissions, IBs etc.
- Stay abreast of the scientific literature for specific clinical indications and competitive drugs. Stay abreast of open data from ongoing company studies.
- Help represent clinical research on project core teams.
- Interact with regulatory to shape clinical strategy and regulatory agency responses
- Work with Clinical Operations to support ongoing studies and support datalocks