Sr. Director, Clinical Operations

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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 Responsibilities:
Develop and implement clinical project plans in accordance with corporate objectives
Evaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnerships
Provide 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 milestones
Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial
Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
Identify, evaluate, and recruit clinical trial sites
Contribute to global clinical / regulatory submissions
As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency
Undertake line management responsibilities for assigned team members, serving as coach and mentor
Contribute to the development of departmental SOPs and work instructions
May require travel, including international travel
Candidate Requirements:

Bachelor’s Degree (scientific discipline preferred); advanced degree preferred
Minimum 12 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 10 years of clinical operations experience; minimum 5 years in a supervisory role
Proven record of success running complex drug development trials
Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
Highly organized, outcome oriented, self-motivated performance
Comfortable in a fast-paced environment with the ability to adapt to change
In 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 budget
Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents