Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
Summary of Position:
Scholar Rock is looking for our next rock star to lead clinical operations for our immuno-oncology programs. This Director level position reports directly to the VP of Clinical Operations and works collaboratively with the broader oncology development team to advance the science into the clinic and to bring medicines to patients who desperately need them. For the right individual this role will not only lead and develop a team of clinical operations professionals, but provide an opportunity to work with accomplished drug developers who are passionate about the work and driven to help patients in need.
Position Responsibilities include:
- 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, including hiring plans and external budgets
- 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
- Assist in the identification and activation of clinical sites
- Contribute to global clinical / regulatory submissions
- Communicate study updates to senior leadership and in open forum presentations
- Undertake line management responsibilities for assigned team members, serving as coach and mentor
- Develop and maintain oversight of departmental SOPs to ensure compliance
- May require travel, including international travel
- 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 early-phase oncology/ immuno-oncology drug development programs
- 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 small biotech 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