Medical Communications Manager

Cambridge, MA /
Medical Affairs /
Full-Time
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 primary focus of the Medical Communications Manager will be the creation and ownership of materials and processes for our Medical Communications function. This person will be a hands on leader and will conduct literature reviews, perform reference searches, and develop abstracts, posters, slide decks, review articles and scientific manuscripts. Although a physical presence in Cambridge is preferred, we would consider a remote employee who was able to travel to Cambridge monthly.

Responsibilities:

    • Lead the development of the publication plans for SRK-015 and SRK-181 and track success towards those plans.
    • Assist in the identification of medical/clinical/scientific gaps of the molecules in development and then design and lead the publication planning to close those gaps, ensuring alignment with the Global Medical Lead and the medical plan.
    • Draft, edit, and submit abstracts, posters, and manuscripts targeted for publication in peer reviewed journals and key medical congresses.
    • Work closely with both internal stakeholders (e.g., Medical Affairs, Clinical Development, Biostatistics, Regulatory, etc.) and external stakeholders (e.g., authors, HCPs, KOLs, etc.) to ensure the timely development, review, and publication of documents.
    • Manage the internal review and approval processes (team review and comments resolution, QC checks, finalization and approvals), and submission process (e.g., interface with journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.)
    • Lead the development of slide decks, white papers, training modules, product monographs, HCP/Payor materials, etc. as needed.
    • Lead the development of company guidelines and SOPs pertaining to the publication function.

Qualifications:

    • Advanced life sciences (MS, MA) or other relevant scientific discipline degree. Doctoral degree (PhD, MD or PharmD) preferred.
    • A minimum of 5 years of experience in writing/editing scientific documents/publications experience in the biotechnology, pharmaceutical, medical device, or medical communications industries. Exposure to orphan diseases and/or oncology is a plus.
    • Experience with building a Med Comm's function from the ground up.
    • Expertise in Good Publication Practice, ICMJE guidelines, AMA style and other applicable industry guidelines.
    • Experience submitting abstracts and manuscripts to congresses and journals.
    • Experience in creating medical content for use by field medical teams.
    • Excellent writing ability with strong editorial and formatting skills.
    • Strong verbal communication, interpersonal, and organizational skills.
    • Ability to convey scientific data and communicate key messages in a clear and concise manner.
    • Ability to work cross functionally, collaborate, negotiate with and influence stakeholders at all levels of the organization.
    • Commitment to scientific accuracy with ability to read the primary literature and analyze data.
    • Intermediate knowledge of biostatistical and clinical research concepts.
    • Familiarity with project management tools, electronic literature search tools and obtaining copyright permissions.
    • Strong Microsoft Office (Word, Excel

Travel Requirements:

    • Ability to travel up to 20%
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees