The Senior Director, Clinical Operations will be responsible for the oversight of multiple and/or large, global clinical studies within a research program(s). He/She will be responsible for the execution of a clinical program and will be responsible for leading a multidisciplinary cross functional team within and outside the clinical development area to ensure departmental and corporate goals and objectives are met on time and within budget. He/she will ensure clinical studies are planned and conducted efficiently with highest quality and in accordance with Halozyme SOPs and ICH guidelines. He/She will also be responsible for the oversight of Clinical Operations quality systems and processes. He/She will support the planning, oversight and implementation of systems, process, and training to support the execution of clinical trials associated with multiple clinical projects.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
- Oversee, implement, manage and execute multiple and/or large global clinical studies across one or more indications and/or drugs including the development and management of budgets, contracts, study metrics, internal and external activities, site activities and resource management
- Select and manage Contract Research Organizations (CROs) and/or other study vendors
- Lead the Clinical Operation Study Team(s) including in-house team members and CROs, vendors and other suppliers
- Oversee and manage the performance of CROs, Contract Laboratories, IRT and other vendors associated with the conduct of a clinical study
- Lead the Study Execution Team(s) and facilitate the cross functional team meetings, including preparation of agenda, materials and minutes
- Provide study updates to program and management teams
- Develop and coordinate operational plans for multiple clinical studies within or across development programs to include study timeline projection, enrollment plans, site engagement plans, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan, communication plan, and CRO oversight plan
- Ensure compliance with SOPs, GCP and ICH guidelines.
- Serve as point of escalation and ensure quality assessments and remediation steps are taken, as appropriate
- Develop and execute plans for external meetings with investigators at national and international congresses; prepare presentations and present at conferences
- Responsible for the clinical section and overall development update for annual report, IB, CSR, and other BLA submission documents
- Implement quality improvement and quality resources for Clinical Operations
- Provide leadership for and oversight of document management and trial master files (TMF) within Clinical Operations
- Select, implement and train for systems supporting clinical operations work (e.g., CTMS)
- Develop, populate and maintain a database of information related to clinical trials including sites lists, investigator lists, study metrics, and key performance indicators (KPIs) across clinical studies
- Manage, lead and mentor employees and contractors
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
- Represent the company at clinical sites and external project meetings as required
- Participate and Lead Departmental initiatives
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
A minimum of a BA/BS in science, or nursing with at least 12 years’ experience in clinical research including strong oncology drug development experience (an equivalent combination of education and experience may be considered)
- Proven leadership skills; must be able to convince people to follow
- Strong interpersonal and project management skills
- Strong knowledge and understanding of the science of the therapeutic area
- Strong working knowledge and applicable understanding of CFR and ICH guidelines
- Strong working knowledge of quality systems and their application in clinical trials
- Good understanding of clinical study implementation process
- Excellent verbal, written communication, and presentation skills
- Must be able to review clinical study tables and listings to ensure clinical data integrity
- Master’s or PharmD degree preferred
- Experience with studies including collection and processing of biopsy for clinical diagnostics preferred.
- Regulatory inspection support experience preferred.
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Microsoft project.
INTERNAL AND EXTERNAL RELATIONSHIPS:
- Manage the relationship with clinical study site staff, including investigators, study coordinators, pharmacists, as well as other relevant functions
- Lead a multidisciplinary cross functional team within and outside the clinical development area including data management, regulatory, quality assurance, drug supply, safety, legal, and finance
- Must be able to manage the relationship with business partners such as CROs and other service providers
- Must be able to communicate and manage communication internally