job summary: Associate Director, Biosample Management
location: San Francisco, California
job type: Contract
salary: $76.96 - 90.54 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Will be responsible for developing standardized systems and approaches for managing central laboratories and bioanalytical vendors on a day to day operations level for assigned project(s). This includes contributing to the strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities.
- Works with senior Clinical Operations management to implement clinical protocols, data collection systems and final reports.
- Monitors clinical sites, central and bioanalytical laboratory adherence to protocols.
- Interacts with various inside/outside groups to facilitate clinical programs.
- Ensures budgets, schedules and performance requirements are met.
- Contributes to the development, management, and execution of the Clinical Development Plan (CDP) which includes timelines, budget, and resource requirements.
- Contributes to the development and implementation of the clinical program strategy and manages those systems and programs in order to meet Company goals and objectives.
- Provides strategic input into the CDP. Identifies program/resource gaps and proposes solutions.
- Provides weekly central and bioanalytical laboratory updates to senior manager.
- Proposes innovative ideas to help resolve challenges faced by the project team.
- Remains current with medical developments and publications on similar and competitor products.
- Applies this knowledge to current programs.
qualifications: Education & Qualifications
- A Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted.
- A minimum of 10 years Pharmaceutical development experience, at least 4 years managing CROs, and daily management of a central laboratory is required.
- A minimum of 8 years previous management experience is may be required.
- Oncology experience is highly desired.
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Excellent written and verbal communication skills are required.
- Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred.
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.
- Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, GCP (Good Clinical Practice), RMV (Routine Monitoring Visit), ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.