Associate Director/Director, Clinical Operations
Pharmacyclics, Inc. - Sunnyvale, CA

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Leads Sr. Clinical Trial Managers, Clinical Trial Managers, Clinical Research Associates, and/or Clinical Trial Assistants for the implementation of clinical development plans. Maintains department infrastructure and procedures and ensures adherence to PCYCs standards, and all applicable regulations and guidelines. Contributes to technical and managerial leadership and organizational improvement of Clinical Operations. Oversees and accountable for all aspects of clinical studies to ensure studies are completed, on time, within budget, and in compliance with SOPs, FDA regulations and ICH /GCP guidelines. Provides assessment of training needs based on role description and project needs. Performs performance appraisals.

Key Accountabilities/Core Job Responsibilities:
Responsible for all functional activities related to the execution of clinical studies based upon department and corporate goals and objectives

Oversee the tactical implementation of the clinical development plan for all assigned clinical programs by managing the contracts, budget, timelines, resources, enrollment, and site activities

Develop and execute a strategy to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals and are in compliance with all applicable regulations and company policies and procedures

Accountable for the preparation and completion of clinical study protocols, CRFs and other study related materials for all assigned clinical programs

Oversee the data collection activities for all assigned clinical programs. Ensure quality data is available to support annual reports, investigator brochures, regulatory filings, safety summaries, project team summaries, etc

Participates in the analysis of clinical data including input and review of Clinical Study Reports

Accountable for hiring, training, mentoring and managing staff at Sr. CTM level and below and able to perform duties at the Sr. CTM level as required

Oversee activities of subordinates and delegates activities appropriately

Accountable for effective and efficient use of internal and external resources to achieve deliverables and to Implement and mitigate resourcing strategies to deliver best efficiency and value

Responsible for managing the investigational product including supply forecasts, labeling, import, and regulatory issues for all assigned clinical programs

Provide leadership, guidance and direction to assigned staff

Lead the development of therapy area operational strategy in collaboration with key stakeholders

Direct exploratory feasibility exercises at program or indication level

Participates in the evaluation, selection and management of CROs and Vendors

Manages overall clinical trial budget and timelines for all assigned clinical programs

Ensures that projects continue to meet expectations and make business sense

Implements performance standards and is responsible for developing performance metric reports across assigned programs or therapy area

Interacts with and presents to senior management to report clinical operation developments and study or program millstones

Develops and maintains effective working relationships with internal stakeholders and external partners

Responsible for the development of Clinical Operations SOPs, Critical Processes, Guidelines, and/or Work Instructions and accompanying templates

Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, ICH-GCP, and regulations of regulatory authorities

Maintains professional skills by keeping abreast of literature, attending conferences, courses and meetings

Maintains knowledge of regulations, guidelines, policies, and practices for conducting(global/international)clinical trials

Coordinates cross functional efforts to improve clinical development. Identifies issues that may impact the overall project plans and initiates contingency plans, as appropriate

Assists in departmental resource planning, budgeting, and timeline setting to meet the company goals

Partner with other research and development groups to achieve deliverables

Provide leadership in the role of managing projects and as the Clinical Operations representative on study Project Team(s)

Participates in or leads change initiatives including process improvement efforts in Clinical Operations

Build clinical teams and interact in a positive, professional manner

Assist in project quarterly payments

Conduct performance reviews, professional development plans and vacation management of direct reports; facilitate conflict resolution

Travel as required to carry out responsibilities

Perform other duties as assigned

BS/BA/ MS degree in scientific discipline and /or RN License

Understand line management function

Able to prioritize and handle multiple tasks simultaneously

Prior management/supervisory experience

Must have demonstrated expertise in relevant clinical operations activities

Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas

Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results

In-depth knowledge of ICH /GCP guidelines and FDA regulations

Strong working knowledge of drug development process

8 – 10 years CRA experience or 8 years experience in the pharmaceutical/clinical research environment with at least 3 years of CRA experience