Director of Clinical Science
Bristol Myers Squibb
5 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Job Responsibilities
- Acquire and apply knowledge of clinical trial design to develop/oversee study concept synopses and protocols.
- Participate in protocol review discussions (scientific/procedural aspects).
- Collaborate with Medical Writing and Clinical Operations to prepare study protocols, amendments, study manual sections, investigator meeting materials, and related documents.
- Coordinate with medical writing vendors to write/review protocols, ICFs, IBs, and other clinical trial documents.
- Contribute to CRF, Data Management Manual, and Data Analysis Plan design/development/review.
- Review ongoing clinical data and work with CROs to resolve data queries and ensure clean data for database locks.
- Organize/oversee Data Review Committee meetings; prepare slides and materials.
- With MD supervision, address investigator scientific/procedural questions; participate in site initiation and study start-up.
- Establish/maintain relationships with investigators and site staff; provide protocol/study design input.
- Prepare/review data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assist in preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
- Support functional area priorities; anticipate and resolve moderately complex clinical study obstacles.
- Coordinate teams/provide direction; may lead components of departmental strategic initiatives.
- Enter new therapeutic areas and integrate published scientific literature into new study development.
- Provide expert advice internally to resolve moderately complex problems.
Qualifications
- BS in Biological Sciences/healthcare or related field with 8+ years relevant scientific/drug development experience OR MS with 6+ years.
- Or PharmD/PhD with 5+ years in clinical research or clinical pharmacology.
- Fast learner; flexible/adaptable.
- Proficient with Microsoft Office (Excel, PowerPoint) and programs such as SpotFire.
- Knowledge of FDA, EMA, and ICH regulations/guidelines.
- Excellent verbal/written communication and interpersonal skills; cross-functional collaboration.
Education And Experience
- As listed in Qualifications.
Application Instructions
- Apply for role R1600239, Director of Clinical Science.
- Acquire and apply knowledge of clinical trial design to develop/oversee study concept synopses and protocols.
- Participate in protocol review discussions (scientific/procedural aspects).
- Collaborate with Medical Writing and Clinical Operations to prepare study protocols, amendments, study manual sections, investigator meeting materials, and related documents.
- Coordinate with medical writing vendors to write/review protocols, ICFs, IBs, and other clinical trial documents.
- Contribute to CRF, Data Management Manual, and Data Analysis Plan design/development/review.
- Review ongoing clinical data and work with CROs to resolve data queries and ensure clean data for database locks.
- Organize/oversee Data Review Committee meetings; prepare slides and materials.
- With MD supervision, address investigator scientific/procedural questions; participate in site initiation and study start-up.
- Establish/maintain relationships with investigators and site staff; provide protocol/study design input.
- Prepare/review data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assist in preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
- Support functional area priorities; anticipate and resolve moderately complex clinical study obstacles.
- Coordinate teams/provide direction; may lead components of departmental strategic initiatives.
- Enter new therapeutic areas and integrate published scientific literature into new study development.
- Provide expert advice internally to resolve moderately complex problems.
Qualifications
- BS in Biological Sciences/healthcare or related field with 8+ years relevant scientific/drug development experience OR MS with 6+ years.
- Or PharmD/PhD with 5+ years in clinical research or clinical pharmacology.
- Fast learner; flexible/adaptable.
- Proficient with Microsoft Office (Excel, PowerPoint) and programs such as SpotFire.
- Knowledge of FDA, EMA, and ICH regulations/guidelines.
- Excellent verbal/written communication and interpersonal skills; cross-functional collaboration.
Education And Experience
- As listed in Qualifications.
Application Instructions
- Apply for role R1600239, Director of Clinical Science.