Director/ Sr. Director, Clinical Operations

Burlingame, California
Apr 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

Role and Responsibilities

·        Contribute to strategic planning to ensure optimized clinical development plans for assigned projects

·        Recommend and implement innovative process ideas to impact clinical trials management

·        Provide direction and leadership in CRO and Vendor selection and management

·        Develop and manage clinical budget and develop contingency plans for clinical trials

·        Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trial report, investigator brochure, etc.) and trial conduct

·        Analyze and develop action plans to address issues with investigational sites, CROs

·        Coordinate closely with Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management and Regulatory to ensure operational excellence

·        Act as a cross functional liaison to ensure study plan aligns with business development strategies

·        Work with other senior managers to establish strategic plans and objectives

·        Participate in corporate development of methods, techniques and evaluation criteria for projects, programs and people

·        Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals

·        Build, manage, and cultivate high performing clinical teams

·        Report on study progress to senior management.

·        Ensure clinical projects remain on schedule and within budget.

·        Review budgets, forecasts, and accruals for clinical studies.

·        Attend advisory panels, investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings

·        Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; setting objectives; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

·        Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment

·        Must have strong negotiation skills with vendors and management in order to influence senior leaders regarding matters of significance to the organization

·        Direct and control the activities of a broad functional area through partnership with cross-functional department managers within the company

·        Has overall control of planning, staffing, budgeting, managing expense priorities and recommending and implementing changes to methods


Qualifications and Education Requirements

·        Bachelor’s degree required

·        Bachelor’s degree or higher in nursing, or health science preferred

·        10+ years of related experience in the pharmaceutical or biotechnology industry with at least 5 years of experience with hematology/oncology indications

·        7 years of line management experience

·        Ability to work on and solve complex problems

·        Ability to prioritize and handle multiple tasks simultaneously

·        Effective leadership skills and proven ability to foster team productivity and cohesiveness

·        Committed to the values of integrity, accountability, transparency, and drive.

·        Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment

·        Must be able to travel up to 10-20%of time on average, may be higher in accordance with company and/or project requirements

·        Local Bay Area candidates preferred


Preferred Skills

·        Excellent teamwork and collaboration skills. Attention to detail required.

·        Proficient with Microsoft Office.

·        Able to build effective working relationships throughout the organization internally and externally to achieve goals.

·        Experience in global trials preferred.

·        Flexibility and willingness to solve problems that fall outside of immediate area of expertise

·        Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.

·        Work independently in an interdisciplinary, fast-paced, often changing environment.