Director, Clinical Operations
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, Clinical Operations
Major tasks and responsibilities include:
We seek candidates with the following qualifications
- Holds leadership within all clinical programs to ensure they are designed, implemented, and completed in accordance with the company’s standards.
- Supports a wide array of clinical programs by keeping a record of relevant developments in the therapeutic area.
- Designs and leads the clinical operations team for specific therapeutic departments while building detailed clinical development plans.
- Guarantees that clinical programs are conducted in compliance with international and local regulations, while making certain that project status is tracked and appropriate timelines are met.
- Acts as the primary representative between research departments and relevant multidisciplinary project team leaders.
- Maintains excellent communication and builds positive working relationships with investigators, key opinion leaders, collaborators, external clients and other company staff.
- Supports clinical project managers in the negotiation of financial and administrative arrangements with external and internal parties.
- Reviews and provides input for key clinical documents for given programs.
- Oversees clinical studies defined in the clinical development plan.
- Organizes actions and resources to meet projected deadlines while maintaining quality standards.
- Assesses the activity and performance of team members and subordinates by establishing objectives and conducting performance appraisals for team members.
- Evaluates adequacy of CROs in collaboration with clinical services and CQA.
- Drives the design and implementation of international clinical operations processes and procedures.
- Upholds and promotes the company’s reputation by demonstrating high professional standards.
- Requires a minimum of an undergraduate degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. Other certifications considered if commensurate with related clinical experience.
- A minimum of 8+ years of relevant clinical research experience within the pharmaceutical industry is required.
- Must have 5+ years of experience leading and managing a team of professional staff.
- Requires proven capability to lead multiple assets.
- Must have a solid understanding of the drug development process, and clinical trial processes.
- Budget forecasting and management is required.
- Must have adequate knowledge of ICH GCP and its applicability to all stages of the clinical development process.
- Specialist knowledge within specific therapeutic areas is desirable.
- Must have the proven ability to plan, execute and complete clinical program projects to the highest ethical and scientific standards.
- Must possess excellent planning, time management & coordination skills.
- Requires the demonstrated ability to problem solve and use adequate judgment in regard to regulatory requirements, interactions with external organizations, timelines and clinical programs.
- Proficiency in reviewing and assessing clinical data is required.
- Must hold extensive knowledge of international GCP guidelines.
- Requires computer literacy in appropriate software.
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.