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:
Here is your opportunity to join a patient-inspired, creative, collaborative, fun and experienced team. Our mission is to help patients with serious illnesses by applying innovative thinking, cutting edge monoclonal antibody and protein science, and our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the Associate Director, Medical Writing will be responsible for developing and managing clinical and regulatory documents for assigned programs. This position requires a highly motivated and enthusiastic professional with hands-on expertise in taking novel compounds from clinical candidate nomination through proof-of-concept and beyond. Key success factors for the position include rare disease and immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer”.
- Independently prepares regulatory and clinical documents including protocols, Investigator's Brochures (IBs), development safety update reports (DSURs), clinical study reports (CSRs), regulatory briefing documents, and clinical sections of regulatory submissions
- Collaborates with cross functional teams to drive document development, review, and finalization timelines with a sense of urgency to meet aggressive corporate goals.
- Ensures documents adhere to standard operating procedures (SOPs), good clinical practice (GCP), and International Council for Harmonization (ICH) guidelines
- Performs quality control review of medical writing documents
- Assists in the development of templates, style guidelines, and SOPs
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required.
- 4-6 years’ experience in a medical writing capacity within the biotech environment.
- Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
- Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology required.
- Detailed knowledge of the requirements for preparation of key clinical, nonclinical, and regulatory documents for INDs, CTAs, BLAs, and annual reports preferred.
- Experience in rare disease and immune-oncology preferred.
- Experience in a start-up environment preferred.
- Must be pro-active team player, flexible, and open to change
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.