Senior Director, Clinical Operations

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as a Sr. Director, Clinical Operations. In this director-level role, you will build and lead a clinical operations team focused on immuno-oncology clinical programs. You will be responsible for operational planning, oversight, and delivery of clinical programs, overseeing clinical trial activities, and ensuring compliance with all SOPs and GCP/ICH guidelines. The position requires a strong leadership background, extensive experience in clinical operations, and a proven track record of successfully managing complex drug development trials. You will also contribute to key study documents, manage a team, and contribute to global clinical/regulatory submissions. This role offers the opportunity to make a significant impact on the development of innovative treatments for serious diseases.

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

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

Preferred Qualifications

May require travel, including international travel