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.
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
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