Associate Director, Clinical Data Management - #1687408

Gated Talent


Date: 1 week ago
City: Cambridge, MA
Contract type: Full time
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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