Vice President, Clinical Development Operations
Our client is a clinical-stage gene therapy company. They have asked us to assist them in a search for a Vice President, Clinical Development Operations
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Reports to the Chief Medical Officer.
- Supports the design, implementation and oversight of the organizational structure and focus of the Clinical Development Organization.
- Forms and maintains relationships with key opinion leaders and investigational site staff responsible for the execution of the company’s trials.
- Leads a high performing Clinical Development Operations team, an area of significant corporate impact, with responsibility for identifying and implementing scalable business process for effective clinical trial execution.
- Has line management responsibility of Director level staff and below.
- Holds responsibility for clinical operations and project management, site engagement, patient enrollment and vendor outsourcing.
- Holds responsibility for strategically planning clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
- Enhances and implements SOPs, processes, communication, and infrastructure within Clinical Development Operations to support company goals.
- Assists in developing a strategic plan for all areas of the company in conjunction with other members of the senior management team.
- Acts as a role model for leadership across the organization, by forming strong working relationships with the colleagues of other functions.
- Coordinates and communicates effectively to promote a collaborative environment, develops reasonable and attainable goals and objectives for each employee and consistently maintains high quality.
- Manages and oversees financial and budgetary aspects of Clinical Department.
- Maintains on-going awareness of developments with the clinical research field and competitive landscape.
- Establishes a strategic outsourcing plan and directs the selection and management of CROs and other vendors for the conduct of clinical trials.
- Develops internal metrics and uses industry benchmarks to assess organizational performance and optimize operational excellence.
- Oversees workforce planning and resource assignments.
- Develops assigned staff competencies and identifies skill gaps to ensure their ability to deliver the required study programs.
- Establishes guidelines for training, sets performance standards and reviews, and mentors and recruits staff.
- Acts as line representative at senior level committees to report on study or program milestones.
- Represents Clinical Development Operations on governance committees with external partners.
- Ensures Clinical Development Operations is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law.
- Serves as the single point of contact for the functional area during inspections by regulatory agencies and health authorities.
- Interacts with company executives and board members.
- Performs other duties as assigned.
- A Bachelor’s degree in science from an accredited college or university is required.
- Requires at least 15 years of clinical operations experience in multiple therapeutic areas.
- A minimum of 7 years of proven supervisory experience is required.
- Must have experience in industry with expertise in the areas of clinical operations, development, and strategic planning.
- Must have significant experience with early to late-stage clinical trials, and with the IND to BLA process, including direct experience in regulatory inspections.
- The ability to manage clinical operations for a product from pre-clinical through all clinical phases and product launch is required.
- Must have an expert understanding of the Good Clinical Practices (GCP), ICH Guidelines, and FDA Regulations with which clinical trials must comply.
- Must possess the ability to build, coach, motivate and supervise a team.
- Significant leadership and management experience in the biotechnology or pharmaceutical industry is required.
- Must hold experience with resource planning as it relates to studies.
- Excellent written and verbal communication skills, including the ability to articulately present information and lead effective meetings are required.
- Must demonstrate competency in applying solid strategic analysis when addressing problems and determining course of action is required.
- The ability to adapt management style to many different situations and give guidance to others in appropriate style development is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.