Senior Director, Clinical Operations

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.  Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
Scholar Rock is looking for a director-level subject matter expert to build and lead a clinical operations team focused on advancing our immuno-oncology 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 C