Sr. Director, Clinical Operations
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Job Description--is looking for a director-level subject matter expert to build and lead a clinical operations team focused on advancing our clinical programs while upholding our core values and staying true to our mission. Reporting to the Head of Clinical Operations, the Sr. Director, Clinical Operations will play a key role in the operational planning, oversight, and delivery for one or more clinical programs.Position ResponsibilitiesDevelop and implement clinical project plans in accordance with corporate objectivesEvaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnershipsProvide oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical trials.Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)Proactively develop and implement hiring plans to attract, recruit, on-board and retain best in class talent to effectively execute against program milestonesEnsure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trialProactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budgetIdentify, evaluate, and recruit clinical trial sitesContribute to global clinical / regulatory submissionsAs a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiencyUndertake line management responsibilities for assigned team members, serving as coach and mentorContribute to the development of departmental SOPs and work instructionsMay require travel, including international travelCandidate RequirementsBachelor's Degree (scientific discipline preferred); advanced degree preferredMinimum 12 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 10 years of clinical operations experience; minimum 5 years in a supervisory roleProven record of success running complex drug development trialsDemonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational developmentHighly organized, outcome oriented, self-motivated performanceComfortable in a fast-paced environment with the ability to adapt to changeIn depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budgetExcellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skillsAbility to analyze complex issues to develop relevant and realistic plans, programs and recommendationsExcellent working knowledge of federal regulatory requirements and guidelines for Good Clinical PracticeOutstanding oral and written communication skills including experience authoring clinical protocols and other key trial documentsThe Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology
• IndustriesStaffing and Recruiting

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