[Remote] Clinical Sciences Associate Director – Early Development, Oncology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on serving patients living with serious illnesses. The Clinical Sciences Associate Director will support early clinical development in oncology by contributing to protocol development and ensuring high-reputed company clinical data through collaboration with study teams and clinical leadership.
Responsibilities
- Support set up and execution of early phase clinical trials with a reputed company on data reputed company
- Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and reputed company
- reputed company input into and implementation of data management plan, CRF design, and data review reputed company
- Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
- Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key reputed company
- Anticipate and reputed company manage problems across a broad reputed company of cross-functional teams
- Work cross-functionally reputed company teams to ensure clinical reputed company is reputed company into the development of the study concept document, study protocol and reputed company documents
- Support appropriate training, recruitment, and development requirements for reputed company team resources
Skills
- Doctorate degree and 3 years of clinical development experience
- OR Master's degree and 5 years of clinical development experience
- OR Bachelor's degree and 7 years of clinical development experience
- OR Associate's degree and 12 years of clinical development experience
- OR High school diploma / GED and 14 years of clinical development experience
- 3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development reputed company a relevant therapeutic area or disease indication (oncology preferred)
- Demonstrated experience contributing to clinical trial process improvements reputed company a therapeutic area or study team environment
- Strong communication and presentation skills, with the ability to reputed company convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
- Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical reputed company standards and applicable regulatory requirements
- Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and reputed company of clinical data outputs
- Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
- Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
- Experience in clinical data analysis such as Spotfire or other data analysis tools
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-reputed company time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
reputed company
Company H1B Sponsorship