Associate Director, Clinical Data Management
Location
Cambridge, MA | United States
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: The Associate Director, Clinical Data Management is responsible for oversight for one or more clinical programs. The person in this role may supervise other Data Management personnel, internal and/or external consultants and service providers. The person in this role will also assume the role of Lead Clinical Data Manager for one or more studies, as needed.
Position Responsibilities - Oversight of Clinical Data Management activities (vendor selection, vendor management and approve DM related documents, SOW and budget review, timeline etc) for one or more clinical programs.
- Manage Data Management staff to support clinical development programs including department vision and expectations aligned with corporate goals for direct reports.
- Contribute to key study documents in conjunction with other functional area leads, (e.g., protocols, project plans, statistical analysis plans, final study reports, etc.).
- Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of trial(s).
- Proactively identify, resolve, and escalate issues that jeopardize clinical study completion on time or within budget.
- Proactively perform and adhere to study data review plans and manage functional team reviews.
- Contribute to global clinical / regulatory submissions.
- Undertake Line Management responsibilities for assigned team members, serving as coach and mentor.
- Contribute to the development of departmental SOPs and work instructions.
- Travel, including international, to support business needs.
Requirements - BS degree in a scientific discipline; advanced degree preferred.
- Minimum 10 years demonstrated experience in a biotech/pharmaceutical/CRO company, principally in rare disease drug development; minimum 7 years Clinical Data Management; minimum 4 years in supervisory role.
- 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 Data 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.
- Working knowledge of the drug development process from pre-IND through NDA and guidelines for Good Clinical Practice.
- Strong knowledge and experience of EDC, IxRS, ePRO systems.
- Strong knowledge of industry standards.
- Outstanding oral and written communication skills.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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