Company
Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
The Senior Clinical Trial Manager may be responsible for all operational aspects of a clinical study from setup through final report, with support from Clinical Operations Leadership. Depending on the size of the study, the Clinical Trial Manager may coordinate the activities of several other clinical team members (e.g. Clinical Research Associates, Data Managers), as well as several external clinical vendors and/ or consultants. The Senior Clinical Trial Manager may also assume the role of supporting an ongoing study in a key role (i.e., the in-house Lead Clinical Research Associate for a study, Trial Master File Specialist), as needed.
Position Responsibilities:
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- Implement clinical project plans in accordance with key study documents (e.g. protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
- Facilitate internal project team meetings
- Ensure trial master file (TMF/eTMF) is established, current, and maintained.
- Drive all aspects of study start-up, including CRO selection
- Point of contact for sites, vendors and CROs
- Monitor CRO and vendor adherence to scope of work
- Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with all regulatory requirements
- Proactively identify, resolve, and escalate issues that jeopardize timely clinical study completion
- Develop and manage clinical trial budget and facilitate contract review
- Participate in vendor, site and CRO audits as appropriate
- Participate in site monitoring visits as necessary
- Plan and present at Investigator Meetings, company, and other meetings as necessary
- Develop internal tracking and reporting tools for reporting study status to Leadership
- Adhere to all department SOPs, GCP/ICH guidelines, and QC/QA procedures
- May require international and domestic travel (up to 20%)
- Other duties and responsibilities as required
Candidate Requirements:
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- BS/BA degree in a scientific discipline; advanced degree preferred
- Minimum of 5+ years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company
- Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
- Prior experience providing oversight of TMF/eTMF
- Highly organized, outcome oriented, self-motivated performance
- Thrives in a fast-paced and evolving environment
- 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
- Understanding of the drug development process
- Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
- Strong written and oral communication skills
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.