Director/Senior Director, Clinical Operations
Mountain View, CA

JOB SPECIFICATION

The Company

The Company is a biopharmaceutical company focused on the development of adaptable non-absorbed polymeric drugs to satisfy unmet clinical needs in large markets such as End Stage Renal Disease (ESRD), Congestive Heart Failure (CHF), Chronic Kidney Disease (CKD), and Hypertension.

The Position

The Director/Senior Director, Clinical Operations reports to the Chief Medical Officer and Senior Vice President of Research & Development.

Professional Responsibilities

• Provides strategic direction on all operational aspects of clinical trials set-up and management.
• Contributes to clinical development plans.
• Performs or directs high-level study feasibility to optimize clinical trial execution.
• Determines costs and resources needed to execute clinical development plans.
• Ensures project key deliverables are met.
• Contributes to establishing departmental processes ensures adherence to The Company's standards, and all applicable regulations and guidelines.
• Contributes to the technical and managerial leadership and organizational improvement of Clinical Operations.
• Manages staff and provides assessment of training needs based on role description and project needs.
• Ensures that proper activities are undertaken for the timely and quality set-up, and planning of clinical studies
• Management of clinical trials to meet The Company's corporate objectives
• Manages interdepartmental scientific and medical activities specific to implementation and conduct of protocols - may lead clinical development sub-teams
• Reviews and approves clinical outsourcing specifications for RFPs
• Ensures adherence to The Company's SOPs, policies and all applicable regulations and guidelines
• Ensures the collection of high quality clinical data; participates in the analysis of clinical data
• Ensures departmental processes are efficient and comply with applicable regulatory requirements
• Ensures proper and timely resolution of CQA audit findings
• Leads and/or coordinates initiatives to improve processes within Clinical Operations
• Ensures a high level of customer service for clinical study sites and internal clinical study teams
• As required, develops and maintains long-term relationships with key investigators, opinion leaders, other industry leaders
• Helps set departmental strategy for capacity management and help set departmental goals
• Participates in or leads change initiatives including process improvement efforts
• Stays abreast of latest developments in clinical trial management, drug development, and, where possible, contribute to advances in the field
• Promotes and communicates the role of the Clinical Operations department (internal/external; scientific/process)
• Provides input and due diligence to in-licensing proposals

Candidate Requirements

• 7-10 years experience of progressively increasing clinical research/development experience within the pharmaceutical industry.
• Experience in drug development, especially FDA (&European) and local regulations and ICH-GCP.
• Profound experience in clinical trial management, in particular with international and global trials.
• An advanced degree (M.S. or PharmD) is preferred. A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine required. Experience requirements may be less with advanced degrees.
• Excellent problem solving and communication skills, excellent team building skills.
• Excellent management & leadership skills
• Has run clinical operational activities with minimal supervision.
• Ability to deliver oral presentations and write in a clear, focused, and concise manner.