Director, Medical Affairs Operations (Contractor)
- Scholar Rock Inc.
- Temporary
- Cambridge, Massachusetts
- Posted: August 28, 2021
Company
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, and fibrosis. 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 forms 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 first investigational product candidate, apitegromab (SRK-015), is a selective inhibitor of the activation of latent myostatin. We announced positive 12-month top-line data from the TOPAZ trial in April 2021, demonstrating that apitegromab has the potential to improve motor function in patients with Type 2 and Type 3 spinal muscular atrophy (SMA). We anticipate initiating a Phase 3 registrational trial by the end of 2021 and are moving steadfast towards our aim of bringing this potential first muscle-directed therapy to patients with SMA
Our second investigational product candidate, SRK-181, is a selective inhibitor of latent TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapies (CPIs), such as anti-PD-1 or anti-PD-L1 antibodies. Although CPIs have transformed the cancer treatment landscape, only approximately 20% of patients respond to treatment. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from CPIs. We are evaluating SRK-181 in the ongoing DRAGON Phase 1 proof-of-concept trial (NCT04291079) evaluating patients with locally advanced or metastatic solid tumors. We anticipate initial clinical response and safety data from Part A (dose escalation) portion of the trial by the end of 2021.
We continue to progress our scientific platform and preclinical programs as we apply our structural insights and protein science and antibody expertise to discover antibodies with differentiated therapeutic profiles and develop high-impact medicines for patients suffering from serious diseases.
Summary of Position:
The Director of Medical Affairs Operations will build out the operational infrastructure, manage business and operations across the growing Global Medical Affairs (GMA) department. Along with the Head of Global Medical Affairs, this person will establish a strong foundation of a medical affairs department to help with the company with pre-launch activities and beyond. The ideal candidate will be a strong leader with a strategic and innovative style combined with a flexible, hands-on nature that works with a high sense of urgency
Key Responsibilities
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- Lead business, strategic and tactical operational planning across the Global Medical Affairs department
- Execute key operational activities and associated processes through GMA (Medical Communications and Publication Planning, Medical Information, Grants, Investigator Initiated Research and Medical Education, GMA vendor management, etc.)
- Evaluate and create business practices, processes, and resources to ensure efficient and effective Medical Affairs Operations
- Develop collaborative cross-functional relationships within SRRK to ensure effective management across departments
Qualifications:
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- PhD, MBA or MS degree in scientific or business discipline
- 7+ years of Pharmaceutical industry experience with relevant experience in Medical Affairs required.
- Experience creating, leading and executing Medical Affairs Operational activities from the ground up preferred. Prior launch experience also preferred.
- Strong organizational, business and budget planning experience
- Previous hands-on experience working with Global Medical Affairs systems, such as Veeva Vault Medical Communications, highly sought
- Flexible and able to work on multiple projects with aggressive timelines, in a small, growing biopharmaceutical company. Must be hard-working, energetic and passionate about making a difference with the highest integrity; committed to ethics and scientific standards.
- Excellent written and oral communication skills are imperative.
- Ability to work independently yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment.
- Strong interpersonal skills and project management skills.
- Ability to be self-motivated, taking self-directed initiative to solve complex and challenging problems. Ability to effectively operate in a small, growing biopharmaceutical company.
- **Remote work available.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.