Senior Director, Clinical Science
IDEAYA Biosciences
10 days ago
On-site
South San Francisco, CA
Clinical Research and Development
Responsibilities:
- With the clinical leader, write clinical development concepts/plans for molecules (early oncology focus).
- Draft/revise protocol synopses, protocols, and protocol amendments.
- Write/review informed consent forms; review/adjudicate site-specific ICF requests.
- Partner with Clinical Operations on site selection, start-up, and communication.
- Write/update clinical sections of investigator brochures; lead brochure writing and annual updates.
- Write/review clinical/safety sections of NDAs/MAAs.
- Represent medical/clinical function on study teams; serve on clinical sub-team.
- Review/interprete safety data and serious adverse events.
- Assist with/author clinical study reports and publications.
- Create internal/external clinical slide decks; train colleagues, CRO, and site staff.
- Organize/participate in opinion leader advisory boards; support HA interactions/inspection responses and internal audits.
- Support HA updates/submissions; assist Medical Monitor for Phase 1 (patient safety guidance).
Requirements:
- Bachelor’s degree; strong clinical oncology knowledge from prior clinical development experience.
- Postgraduate clinical oncology preferred (MS); MD/NP license/PharmD/PhD welcomed.
- 4+ years oncology industry experience.
- Essential: participation in clinical development program; ideally all trial stages (start-up to study report).
- Preferred: experience with small-molecule clinical trials; assessment of AEs/patient safety.
- Skills: protocol design/interpretation; medical monitoring; Good Clinical Practice; excellent written/oral communication; adapt to fast-paced change; English fluency.
Total Rewards (explicit):
- Medical/dental/vision (100% company paid for employees; 90% for dependents), 401k, ESPP, wellness programs; expected salary range: $276,000–$341,000.
- With the clinical leader, write clinical development concepts/plans for molecules (early oncology focus).
- Draft/revise protocol synopses, protocols, and protocol amendments.
- Write/review informed consent forms; review/adjudicate site-specific ICF requests.
- Partner with Clinical Operations on site selection, start-up, and communication.
- Write/update clinical sections of investigator brochures; lead brochure writing and annual updates.
- Write/review clinical/safety sections of NDAs/MAAs.
- Represent medical/clinical function on study teams; serve on clinical sub-team.
- Review/interprete safety data and serious adverse events.
- Assist with/author clinical study reports and publications.
- Create internal/external clinical slide decks; train colleagues, CRO, and site staff.
- Organize/participate in opinion leader advisory boards; support HA interactions/inspection responses and internal audits.
- Support HA updates/submissions; assist Medical Monitor for Phase 1 (patient safety guidance).
Requirements:
- Bachelor’s degree; strong clinical oncology knowledge from prior clinical development experience.
- Postgraduate clinical oncology preferred (MS); MD/NP license/PharmD/PhD welcomed.
- 4+ years oncology industry experience.
- Essential: participation in clinical development program; ideally all trial stages (start-up to study report).
- Preferred: experience with small-molecule clinical trials; assessment of AEs/patient safety.
- Skills: protocol design/interpretation; medical monitoring; Good Clinical Practice; excellent written/oral communication; adapt to fast-paced change; English fluency.
Total Rewards (explicit):
- Medical/dental/vision (100% company paid for employees; 90% for dependents), 401k, ESPP, wellness programs; expected salary range: $276,000–$341,000.