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Senior / Principal Clinical Scientist

Cambridge, MA - Medical Research Full-Time
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 will be initiated in Q1 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 Senior / Principal Clinical Scientist reports directly to VP & Head of Medical Research for Oncology and will support various aspects of clinical development at Scholar Rock.  We will consider Associate Director for the right candidate. This individual will participate in clinical trial design, clinical data analysis, internal and external communication of the program, and contributions to regulatory submissions, publications and presentations
Responsibilities:
  • Support development of clinical development plans, protocols, and regulatory strategies
  • Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team
  • Support Medical Lead with medical monitoring activities, safety reviews, site interactions, and reviewing TFLs. Perform clinical data review and analysis of study results. Present clinical trial results internally and externally.
  • In collaboration with Clinical Operations and the Medical Lead, review protocol deviations to identify cause and appropriate resolution.
  • 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 Medical Lead.
  • Provide feedback on emerging clinical/competitive trends; understanding competitive landscape and providing insights on strategic development pathways.
  • 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 accomplishing department and corporate objectives.

  • Qualifications:
  • RN, MS, PhD or PharmD, with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred.
  • At least 3 years of Biotech/Biopharma industry experience in oncology drug development.
  • Extensive, direct knowledge of the oncology clinical development process.
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, and regulatory submissions.
  • Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA
  • 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 individually, within a multi-disciplinary team, as well as with external vendors
  • 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