Director, Clinical Operations
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: August 28, 2021
Company
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, and fibrosis. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By exploiting structural differences in the precursor, or latent forms of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
Our first investigational product candidate, apitegromab (SRK-015), is a selective inhibitor of the activation of latent myostatin. We announced positive 12-month top-line data from the TOPAZ trial in April 2021, demonstrating that apitegromab has the potential to improve motor function in patients with Type 2 and Type 3 spinal muscular atrophy (SMA). We anticipate initiating a Phase 3 registrational trial by the end of 2021 and are moving steadfast towards our aim of bringing this potential first muscle-directed therapy to patients with SMA
Our second investigational product candidate, SRK-181, is a selective inhibitor of latent TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapies (CPIs), such as anti-PD-1 or anti-PD-L1 antibodies. Although CPIs have transformed the cancer treatment landscape, only approximately 20% of patients respond to treatment. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from CPIs. We are evaluating SRK-181 in the ongoing DRAGON Phase 1 proof-of-concept trial (NCT04291079) evaluating patients with locally advanced or metastatic solid tumors. We anticipate initial clinical response and safety data from Part A (dose escalation) portion of the trial by the end of 2021.
We continue to progress our scientific platform and preclinical programs as we apply our structural insights and protein science and antibody expertise to discover antibodies with differentiated therapeutic profiles and develop high-impact medicines for patients suffering from serious diseases.
Summary of Position:
The Director, Clinical Operations is responsible for operational oversight for one or more clinical programs. The person in this role may supervise other clinical personnel, as well as internal and/ or external consultants and service providers. The Director, Clinical Operations may also assume the role of Clinical Trial Manager for one or more studies, as needed.
Responsibilities
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- Develop and implement clinical project plans in accordance with corporate and regulatory objectives
- Oversight of clinical operation activities (vendor selection, trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.
- 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.)
- Manage clinical trial resources and reforecasting projections
- Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines
- Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
- Assist in the identification and activation of clinical sites and Principal Investigators for trial participation
- Communicate study updates in open forum presentations
- Undertake Line Management responsibilities for assigned team members
- May require travel, including international travel
Requirements
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- BS/BA degree in a scientific discipline; advanced degree preferred
- 8+ years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company with 6+ years clinical operations/ project leadership experience
- Hands on experience running global clinical trials in rare patient populations
- Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
- Highly organized, outcome oriented, self-motivated performance
- Ability to adapt to change in a growth 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
- Good understanding of the drug development process from pre-IND through NDA
- Excellent working 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.