Job details

Senior Director, Clinical Operations

Get a free resume review

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.

Scholar Rock Glassdoor Company Review

4.1

Scholar Rock DE&I Review

4.2

CEO of Scholar Rock

Unknown name

Approve of CEO

What You Should Know About Senior Director, Clinical Operations, Scholar Rock

As the Senior Director of Clinical Operations at Scholar Rock, you'll be stepping into a pivotal role within a leading biopharmaceutical company dedicated to making a difference in the lives of patients with serious diseases. Our focus is on pioneering innovative therapies that address unmet medical needs, particularly in areas like neuromuscular disease and cancer. Reporting directly to the Head of Clinical Operations, your mission will be to spearhead a dynamic clinical operations team, with a primary focus on advancing our immuno-oncology programs. You'll be instrumental in shaping and implementing clinical project plans that align with our ambitious corporate goals. With a robust background in biotech or pharmaceutical settings, you’ll leverage your extensive experience—over 12 years in the field, including at least 5 years in leadership—to drive the successful execution of complex drug development trials. We’re looking for someone who embodies our core values, thriving in a fast-paced environment, managing partnerships, and ensuring that clinical trials comply with all regulatory guidelines. This is a rare opportunity to influence the direction of transformative therapies at Scholar Rock while fostering an environment that values coaching and mentorship. So if you're ready to make a significant impact in a company with a cutting-edge scientific approach, we’d love to hear from you!

Frequently Asked Questions (FAQs) for Senior Director, Clinical Operations Role at Scholar Rock

What are the primary responsibilities of the Senior Director, Clinical Operations at Scholar Rock?

The Senior Director, Clinical Operations at Scholar Rock is responsible for building and leading a clinical operations team to advance immuno-oncology clinical programs. Key responsibilities include developing clinical project plans, managing trial operations, evaluating outsourcing partnerships, ensuring compliance with regulatory guidelines, and mentoring team members to cultivate excellence.