REPORTS TO (POSITION): Head of Translational Science
LOCATION: San Francisco Bay Area, CA
DEPARTMENT NAME: Translational Science
HR DESIGNATIONS: PAY STATUS – EXEMPT
Objective of Position
The Senior Biosample Operations Manager (Sr. BOM) directs, manages and oversees all operational activities for sample management at Acerta Pharma. This includes key interfaces with the departments of Translational Science, Biology, Qualitative Clinical Pharmacology and Early Clinical Development. The Sr. BOM is responsible for the entire life cycle of a sample spanning collection at clinical trial sites through testing to ensure accurate and verified data reporting. This is a Biosample operations expert role as well as a management role where the Sr. BOM manages and grows a team of Biosample Operations Managers and Associates to ensure correct implementation of clinical trial strategy to obtain clinical trial samples according to local and corporate regulations to enable cutting edge Translational Medicine.
The Sr. BOM establishes workflow and timelines for analytical needs to support Acerta’s corporate goals as part of AstraZeneca’s Heme Center of Excellence. This role ensures sample accuracy and process consistency across late phase and early phase (aRED) studies. This role initiates and nurtures collaboration with business partners and stakeholders of all levels to ensure task completion within project goals and timelines.
Essential Duties/ Responsibilities
- In collaboration with Scientists within Translational Science, QCP, and Biology strategize sample flow for each clinical trial to ensure it meets assay and data output needs
- Liaises with the Study Team of various functions to assess the feasibility for collection during startup
- Grow, manage and nurture sample management team and serve as line manager for BOA and BOM
- Help build the clinical database through reviews, sharing feedback and guidance between Data Management and Biosample Management
- Identify sample collection risks and proactively seek to resolve issues in a timely manner to not disrupt sample flow.
- Establish healthy working relationships with sites, vendors, business partners, and other stakeholders
- Serve as an active member of the Study Management Team, Translations Science sub-team and Clinical Pharmacology sub-team to provide updates on collection progress. May also be an ad-hoc member of the Global Decisions Team
- Complete Action up items and keep track of follow up items to ensure sample management stays within timelines.
- Escalate unresolved urgent issues when needed and creatively and proactively seek to minimize issues for escalation
- Draft, review and finalize laboratory workplans and collection manuals to ensure accuracy and consistency with the study protocol and clinical needs
- Provide training to study team, clinical monitors, and clinical sites as needed
- Create and manage sample trackers, metrics and visual aids for sample collections and procedures
- Understand and assist in data reporting needs for each clinical study
- Establish shipment timelines and facilitate all shipment activities including query resolution as needed
- May present at study team, sub-team or company-wide meetings if appropriate
- Have a strong understanding of scientific needs as well as clinical processes to bridge the needs between these functions
- Point of contact for the management of Acerta’s Central Repository
- Travel as needed for site trainings or other business needs for successful sample management practices
- Ideally +10 years in sample management with increasing levels of responsibility
- Must have a strong knowledge and previous experience in clinical trials and preclinical activities
- Ideally experience in Hematological Malignancies
- Strong organization and communication skills
- Solid scientific knowledge a must
- Must be flexible able to work successfully and fast paced environment
- Must be able to work across different cultures and in national & international time zones
- Proven record of successfully managing multiple competing priorities
- Self-motivated and a quick learner who’s able to take on tasks with minimal direction
- Maintain professional demeanor under stressful situations
- Leader and manager of a team
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.