Sr. Director, Drug Safety Operations
San Francisco Bay Area
A rapidly expanding Oncology-focused Biotech company is looking for a Sr. Director, Drug Safety Operations to join its rapidly expanding team! This company has a diverse pipeline of therapies and is on track for explosive growth in 2019 as it just had its first drug approved this past year. With two more therapies on track for approval in 2021, now is the perfect time to get in with this cutting-edge Oncology company. With the resources of a large pharma company. and its relatively small size, this opportunity provides you with the chance to accelerate career with a growing company along with long term stability.
The Sr. Director, Drug Safety Operations will have the following responsibilities:
- Lead the process of safety CRO selection and evaluation process as needed
- Manage CROs to ensure all timelines are met, potential issues are being communicated and resolution is achieved in a timely manner
- Accountable for identification, initiation, development and implementation of PV process
- Collaborate with case processing team at CRO and develop and report internal tracking metrics related to case processing team at CRO, consultants and/or in-house clinical trial SAE processing and vendor management
- Ensure adequate safety management plan (SMP) is in place for each assigned study/Probody as well as review relevant eCRF forms from clinical database for alignment with safety forms and reconciliation (e.g., AE, study drug administration, disposition)
- Work closely with department head and QA/Regulatory to maintain an effective and compliant system for monitoring the safety profile for individual compounds as well as the platform
- Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to ensure quality and consistency in safety operations, data output, studies and programs.
- Ensure registration of product study/CRO personnel as required with ex¬ US reporting (e.g., Eudravigilance) and SUSAR submission compliance with applicable FDA and global regulations as well as internal Client SOPs
- Provide guidance and appropriate study configuration to safety data management for SAE/AE reconciliation process
- Assist in single case & end-of-study unblinding, deviation memo preparation, deletion/admin edit requests and approvals, review protocol update request forms for accuracy
- Support and guide interim coding review of AEs and concomitant medications (CMEDs) as outlined in study-specific plans
- Author and train to SOPs as required per job function
- Lead the budget planning for the safety operations function and report on ongoing budget initiatives
- Serve as subject matter expert (SME) for audits and inspections as well as ensure preparedness for all safety-related documentation to be filed properly for inspection
The ideal candidate will have the following skill set:
- 10 + years of experience in Pharmacovigilance/Drug Safety operations
- Experience Managing Vendors and People
Compensation:
Competitive Base Salary + Excellent Targetted Bonus + Stock Options + 401k + Medical Benefits