Cambridge, MA /
Medical Affairs /
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 Medical Director/Lead will serve as a Product Medical Lead, within the Scholar Rock Global Medical Affairs (GMA) organization. This position will create the US and possibly the ex-US Medical Strategy for SRK-015 in Spinal Muscular Atrophy (SMA), an Orphan disease, and oversee the execution of it. As the GMA scientific expert, this individual will provide GMA expertise for SRK-015 in SMA. This person will also work in close collaboration with cross functional colleagues in Regulatory, Market Access, Clinical Development, Commercial, Corporate Affairs, Patient Advocacy and other key cross functions. 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.
- Lead the design and execution of the US and possibly the ex-US Medical Strategic Plan for SRK-015 in SMA. This Medical Strategic Plan would include tactics throughout the life cycle management of the product. Additionally, this Medical Strategic Plan would include plans for Medical Communications, Medical Information, Research: RWE, HEOR, IIRs, and Collaborative Studies; Grants, Congress and publication planning, etc.. The Medical Strategic Plan would also identify and address specific unmet medical needs and key data gaps for the product.
- May manage the sub-functions related to the Medical Strategic Plan (Med Comms, Med Info, Publications, etc.) to ensure seamless execution of the Medical Strategic Plan.
- Will be responsible for setting the budget to execute the Medical Strategic Plan.
- Oversee the development of medical messaging for SRK-015. Conduct focused internal GMA training and communication priorities for SRK-015 in SMA.
- Lead the planning and execution of a KOL engagement plans, including the involvement of KOLs at Advisory Boards and/or presentations at national and international meetings. Develop and maintain close professional relationships with KOLs (physicians, physical therapists, other treatment team members), emerging scientific leaders, researchers, Payers, medical societies and patient advocacy groups within the SMA community.
- Provide medical expertise to cross-functional teams. As a content expert, review abstracts, publications, medical information letters, and other medical or commercial documents for promotional and/or scientific use, as needed. This disease area expertise may provide opportunities to present data at national and international medical conferences/congresses.
- Compliantly collaborate with internal colleagues to ensure alignment with the Medical Strategic Plan and to ensure that key internal stakeholders are sufficiently aware of insights and needs gained from interactions with external customers.
- MD, PhD, PharmD or other advanced degree in the life sciences.
- 5+ years of Pharmaceutical industry experience with relevant experience in Medical Affairs required.
- Experience developing and executing medical strategies. Prior experience as Medical Director/Lead highly preferred.
- Experience with rare disease and/or musculoskeletal disorders is desired.
- 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.
- Ability to understand and effectively communicate scientific and medical information to both internal and external stakeholders. 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.
- Experienced and demonstrated success with publications, internal training, statistical analysis, medical communications, and core GMA functions.
- Strong background in ethical evaluation of research projects and proven ability to conduct medical and scientific analysis and decision-making.
- 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.
- Willingness to travel 40-50% of time to attend 1:1 KOL meetings, Medical Congresses and Medical Society meetings.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.