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 seeking an outstanding individual with experience in nonclinical toxicology to join our research team in discovering and developing novel biologic therapies that target protein growth factors in the disease microenvironment. The successful candidate will be involved in assessing potential toxicities of novel antibodies that specifically modulate the function of disease-causing growth factors in such therapeutic areas as musculoskeletal diseases, fibrosis, cancer, hematology and autoimmunity.
- Plan, execute and monitor toxicology studies for advancing candidates through lead optimization, candidate selection and into IND-enabling studies and beyond.
- Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities.
- Review, summarize, interpret and report results of toxicology and safety pharmacology studies.
- Provide strategic advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
- Provide nonclinical study support to research, clinical and regulatory teams (including timing and reporting of all nonclinical studies and assuring compliance with all appropriate regulatory guidance).
- Ability to both prepare and critically evaluate written scientific and regulatory documents for overall quality, clarity of presentation, and acceptability of scientific interpretation.
- Capable of highly effective interactions with regulatory bodies in the process of product defense and support of global regulatory submissions.
- Work closely with program leaders, clinical and regulatory teamsto develop an overall toxicology development plan.
- Ph.D. in Toxicology or relevant field; with a minimum of 5 years of experience in nonclinical development and proven track record of conducting regulatory toxicology studies (DABT certification preferred but not required).
- Proficient knowledge and hands-on experience in all aspects of toxicology study conduct including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology.
- Experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology studies to assist lead optimization and candidate selection efforts (experience with biologic drugs preferred).
- Experienced in management of external CROs.
- Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology and pathology assessing the clinical relevance and impact.
- Familiarity with GLP requirements and ICH guidelines.
- Proficient in scientific documentation (IND, IBs. NDAs etc.) supporting submissions to regulatory agencies (FDA, EMA).
- Experience representing function to global regulatory agencies in support of submissions.
- Strong interpersonal skills to work effectively in a team setting/matrix-type organization.
- Critical problem solving and organizational skills required.
- Excellent oral and written communication capabilities, essential for successful contributions.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.