Job description
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 Clinical Practice
- Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
