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 Medical and Scientific Director will serve as a Global Medical Lead, within the Scholar Rock Global Medical Affairs (GMA) organization. This position will create the US and Global Medical Strategy for apitegromab in SMA, an Orphan disease, and be responsible for the co-execution the plan.
As the GMA scientific expert, this individual will provide GMA expertise for apitegromab 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 GMA team to plan and deliver on scientific narrative for the brand, including the scientific engagement and medical performance for apitegromab via a Medical Strategic Plan.
Guide the sub-functions related to the Medical Strategic Plan (Med Comms, Med Info, Publications, IME, HEOR, IIRs, Phase IV studies, Global KOL engagement planning, etc.) to ensure seamless execution of the Medical Strategic Plan and co-development of the medical/scientific messaging.
Internally socialize the Medical Strategic Plan and align with cross-functional colleagues as appropriate
Establish and manage the budget and headcount related to the Medical Strategic Plan for apitegromab in SMA
When applicable, lead the design and execution of Phase IIIB/ IV evidence generation studies, including post-approval commitments; Manage IIRs; Lead/Contribute to LCM activities
Be the lead as the externally facing GMA representative for apitegromab. Build and maintain relationships with US and Global KOLs (physicians, physical therapists, and other treatment team members) and other emerging medical/clinical/scientific leaders, researchers, Payers, professional societies/organizations and patient advocacy groups within the SMA community
Gather insights from key external stakeholders to help shape the Medical Strategic Plan
Lead Advisory Board meetings, conduct data presentations at congresses, and other externally facing company events.
As needed, will conduct internal trainings for cross-functional partners.
(physicians, physical therapists, other treatment team members), emerging scientific leaders,.
Provide medical expertise to GMA and other cross-functional teams, such as Commercial. As a content expert, review promotional materials, abstracts, publications, medical information letters, and other medical or commercial documents for promotional and/or scientific use.
Compliantly collaborate with internal colleagues to ensure alignment with the Medical Strategic Plan and ensure timely communication with internal colleagues re: insights and needs gained from interactions with external customers.
MD/DO (preferred), PhD, PharmD or other advanced degree in the life sciences with 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.
Local candidates preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.