Clinical Science Director
Exelixis
5 hours ago
Remote friendly (Alameda, CA)
United States
$195,000 - $277,500 USD yearly
Clinical Research and Development
Clinical Science Director designs, plans, and develops early and/or late phase clinical oncology studies; prepares and authors clinical development documents (study synopses and protocols); summarizes study results for documents and publications; provides scientific support and progress updates.
Responsibilities:
- Design, prepare, and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- Facilitate design of clinical synopses and protocols with investigators and oncology thought leaders.
- Research and assist in selecting investigators.
- Conduct literature research for assigned clinical product candidate.
- Collaborate to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Serve as contact for medical monitor inquiries (with oversight/guidance for the assigned Medical Monitor).
- Collaborate on agendas, training materials, and presentations for site visits and investigator meetings.
- Participate in internal safety meetings; analyze and report potential safety events.
- Support clinical review/interpretation of study data for health authority reports, regulatory filings, and study close-out reports.
- Contribute to writing/review of abstracts and publications; support presentations for scientific meetings.
- Provide feedback on emerging clinical and competitive trends.
- Coordinate and facilitate studies; maintain strong working relationships with investigators.
- Deliver scientific presentations to physicians and external customers.
- Provide clinical education support to internal customers.
- Maintain clinical and technical expertise in Oncology.
Education/Experience (required):
- Pharm.D., PhD, or M.D. and minimum 8 years of related experience; or equivalent combination of education and experience.
Experience (preferred/ideal):
- 5–8 years clinical development experience in biotechnology/pharmaceutical industry (or equivalent academia/industry mix).
- Participation in clinical oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills (required):
- Detailed knowledge of clinical trial implementation and drug development process.
- Experience designing, executing, and reporting oncology clinical trials with small and large molecule candidates.
- Ability to implement methods/procedures to achieve high-quality results.
- Strong analytical and business communication skills; highly organized; able to work under tight timelines.
- Good public speaking and presentation skills.
- Broad application of technical principles/theories/concepts; judgment in selecting methods and evaluation criteria.
Working Conditions:
- 10–25% travel requirement.
Responsibilities:
- Design, prepare, and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- Facilitate design of clinical synopses and protocols with investigators and oncology thought leaders.
- Research and assist in selecting investigators.
- Conduct literature research for assigned clinical product candidate.
- Collaborate to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- Serve as contact for medical monitor inquiries (with oversight/guidance for the assigned Medical Monitor).
- Collaborate on agendas, training materials, and presentations for site visits and investigator meetings.
- Participate in internal safety meetings; analyze and report potential safety events.
- Support clinical review/interpretation of study data for health authority reports, regulatory filings, and study close-out reports.
- Contribute to writing/review of abstracts and publications; support presentations for scientific meetings.
- Provide feedback on emerging clinical and competitive trends.
- Coordinate and facilitate studies; maintain strong working relationships with investigators.
- Deliver scientific presentations to physicians and external customers.
- Provide clinical education support to internal customers.
- Maintain clinical and technical expertise in Oncology.
Education/Experience (required):
- Pharm.D., PhD, or M.D. and minimum 8 years of related experience; or equivalent combination of education and experience.
Experience (preferred/ideal):
- 5–8 years clinical development experience in biotechnology/pharmaceutical industry (or equivalent academia/industry mix).
- Participation in clinical oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills (required):
- Detailed knowledge of clinical trial implementation and drug development process.
- Experience designing, executing, and reporting oncology clinical trials with small and large molecule candidates.
- Ability to implement methods/procedures to achieve high-quality results.
- Strong analytical and business communication skills; highly organized; able to work under tight timelines.
- Good public speaking and presentation skills.
- Broad application of technical principles/theories/concepts; judgment in selecting methods and evaluation criteria.
Working Conditions:
- 10–25% travel requirement.