Director, Clinical Operations, Oncology
- 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:
Scholar Rock is looking for a director-level subject matter expert to build and lead a clinical operations team focused on advancing our immuno-oncology clinical programs while upholding our core values and staying true to our mission. Reporting to the Head of Clinical Operations, the Director, Clinical Operations will play a key role in the operational planning, oversight, and delivery for one or more clinical programs.
Position Responsibilities
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- Develop and implement clinical project plans in accordance with corporate objectives
- Evaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnerships
- Provide oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical trials.
- 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.)
- Proactively develop and implement hiring plans to attract, recruit, on-board and retain best in class talent to effectively execute against program milestones
- Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial
- Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
- Identify, evaluate, and recruit clinical trial sites
- Contribute to global clinical / regulatory submissions
- As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency
- Undertake line management responsibilities for assigned team members, serving as coach and mentor
- Contribute to the development of departmental SOPs and work instructions
- May require travel, including international travel
Candidate Requirements:
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- Bachelor’s in a scientific discipline; advanced degree preferred
- Minimum 10 years of experience in a biotech/pharmaceutical/ CRO setting, principally in oncology drug development; minimum 7 years of clinical operations experience; minimum 5 years in a supervisory role
- Proven record of success running oncology/ immuno-oncology drug development trials
- 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 operations 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
- Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
- Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.