Vice President, Clinical Development Operations
Our client is a biotechnology company developing medicines for neurodegenerative diseases. They have asked us to assist them in their search for a Vice President, Clinical Development Operations
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Creates, executes, and proactively manages clinical trial processes.
- Provides leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources, and budget goals are met.
- Establishes performance indicators to ensure successful execution of clinical trials to agreed timelines.
- Provides key input into all clinical development activities including integrated development plans and study protocols.
- Represents clinical operations and provides updates to the Leadership Team, Project Teams, Board of Directors and other key internal stakeholders.
- Leads and mentors Clinical Operations staff to support successful internal training and professional development of Clinical Operations staff.
- Oversees, plans, and implements Quality Checks to ensure high standards for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards.
- Holds accountability for authorship of operational sections of protocols and investigator brochures, and in leading the identification of and interaction with investigative sites, investigators, and site staff.
- Develops and maintains strong relationships with CROs, external experts, and Investigators.
- Coordinates with biometrics staff to deliver high quality data deliverables on time and on budget (including but not limited to the development of case report forms, collaborations with statisticians, data managers, data review, clinical study reports).
- Provides support for regulatory submissions.
- Manages submissions to ethics committees.
- As a member of the senior management team, assists in developing a strategic plan for all areas of the company in conjunction with other team members.
- Travels domestically and internationally up to 20% of work time.
- Bachelor’s degree or equivalent from an accredited college or university required.
- Must have a minimum of 15 years of pharmaceutical industry experience in clinical operations development and strategic planning, including experience developing, implementing, and leading early- to late-stage clinical trials.
- Must have experience in multiple therapeutic areas. Experience in CNS and/or rare diseases highly preferred.
- Requires experience across clinical operations value chain, with a track record of success in resource planning, study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
- Requires expert understanding of Good Clinical Practices (GCP), ICH Guidelines and FDA/EMA regulations with which clinical trials must comply.
- Experience with global drug development and IND/CTA filing highly preferred.
- Experience in developing protocols, SOPs, CSRs, INDs, NDAs as well as other clinical, regulatory and safety documents highly preferred.
- Requires the demonstrated ability to build, coach, motivate and supervise a team.
- Must possess excellent written and verbal communication skills, including the ability to present information and lead effective meetings.
- The ability to adapt, lead and thrive in a rapidly changing and growing organization is required.
- Must be a results-oriented team player with strong interpersonal and communication skills, with the ability to work collaboratively with colleagues.
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.
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