Director, Clinical Scientist - Muscle Therapeutics
Cambridge, MA /
Medical Research /
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, fibrosis, and anemia. 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 form 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 lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation 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.
Our second product candidate, SRK-181, is a potent and highly selective inhibitor of latent TGFβ1 activation. A Phase 1 proof-of-concept trial was initiated in April 2020 in patients with solid tumors. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from checkpoint inhibitor therapy by overcoming primary resistance to anti-PD-(L)1 antibodies.
Summary of Position:
The Director, Clinical Scientist reports directly to the VP & Head of Medical Research, Muscle Franchise and supports the clinical development of SRK-015 and the SRK-015 program in Scholar Rock. This experienced individual will participate in clinical trial design and conduct, clinical data analysis, internal and external communication of the program, and contribute to strategy discussions, regulatory submissions, publications, and presentations.
- Support development of clinical development plans, protocols, and regulatory strategies
- Contribute to the design and conduct of clinical studies in close collaboration with the Head of Medical Research, Muscle Franchise, as well as the entire Clinical Development Team
- Participate and contribute to Program Team and Study Surveillance Team meetings and activities
- Support the Head of Medical Research, Muscle Franchise, with medical monitoring activities, safety reviews, site interactions, reviewing TFLs and protocol deviations to identify cause and appropriate resolution; perform clinical data review and analysis of study results; present clinical trial results internally and externally
- Support authoring and review of protocols, clinical study reports, IBs, ICFs, training documents, charters, and other clinical and regulatory documents under the direction of the Head of Medical Research
- Support clinical development strategy and plans; provide feedback on emerging clinical/competitive trends and contribute to understanding of competitive landscape and unmet medical needs
- Support preparation of scientific material for conference presentations or publications
- Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations
- Assist in and contribute to accomplishing department and corporate objectives
- Occasionally asked to take on clinical development responsibilities not covered in this description
- RN, MS, PhD, PharmD or equivalent degree(s), with extensive clinical research experience and a strong knowledge of clinical drug development
- At least 10 years of Biotech/Biopharma industry experience in neurology, neuroscience, neuromuscular, rare disease, or pediatric drug development; demonstrated ability to contribute to clinical drug development programs, science, and trials
- Experience in protocol development, study report preparation, IB preparation, and regulatory documents and submissions
- Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g., GCP, ICH, FDA, EMA and PMDA)
- Highly analytical with strong problem-solving, organization, and critical thinking skills
- Strong attention to detail and the ability to manage multiple tasks, especially under aggressive timelines
- Ability to work independently, within a multidisciplinary team, as well as with external vendors and CROs; ability to operate with internal teams and lead based on experience and knowledge
- Flexibility and adaptability working in a clinical-stage Biotech organization
- Excellent written and communication skills
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.