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VP, Regulatory Affairs

Company: HCPro, Inc.
Location: Cambridge
Posted on: September 14, 2020

Job Description:

VP, Regulatory Affairs

Scholar Rock

Cambridge, Massachusetts, United States

30+ days ago

Description

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 TGF?1 activation. A Phase 1 proof-of-concept trial will be initiated in Q1 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:

Our mission is to help patients with serious illnesses by applying innovative thinking and execution, cutting edge science, and our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the VP of Regulatory Affairs will be responsible for driving the global regulatory strategy and its execution. This position requires a highly motivated and talented regulatory professional with strong leadership and expertise in advancing novel compounds from clinical candidate nomination through proof-of-concept (POC) as well as from post-POC through approval and beyond.

Position Responsibilities

* Lead global regulatory strategy and execution for all research and development programs at Scholar Rock

* Build an innovative, world-class, and patient-centric regulatory affairs organization

* Play a key role in overall R&D strategy and decision-making

* Develop and sustain strong relationships between Scholar Rock and regulatory agencies around the world

Requirements

* Inspired by and dedicated to our company's mission to transform the lives of patients affected by serious illness

* Expertise and experience with biologics across the full development path from pre-clinical to approvals and beyond, with a track record of successfully advancing multiple product candidates through global approvals

* Significant, broad expertise with regulatory strategy globally (not just the U.S.) and directing interactions with regulatory authorities

* Strong leadership of not only of one's direct reports and organization but also cross-functional teams

* Demonstrated versatility working within multiple therapeutic areas, with rare diseases/orphan drugs a strong plus

* A Medical or Scientific background is a significant plus, given the highly innovative nature of our R&D efforts

* Creative and flexible but also simultaneously able to keep the team's efforts disciplined, diligent, and on-time

* Highly integrative thinker who understands and considers issues from an inter-disciplinary perspective

* Performs well in an informal, dynamic, highly cross-functional culture (which places importance on strong teamwork and morale)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Job Information

* Job ID: 53159716

* Location:

Cambridge, Massachusetts, United States

* Position Title: VP, Regulatory Affairs

* Company Name: Scholar Rock

* Job Function: Regulatory

* Job Type: Full-Time * Inspired by and dedicated to our company's mission to transform the lives of patients affected by serious illness * Expertise and experience with biologics across the full development path from pre-clinical to approvals and beyond, with a track record of successfully advancing multiple product candidates through global approvals * Significant, broad expertise with regulatory strategy globally (not just the U.S.) and directing interactions with regulatory authorities * Strong leadership of not only of one's direct reports and organization but also cross-functional teams * Demonstrated versatility working within multiple therapeutic areas, with rare diseases/orphan drugs a strong plus * A Medical or Scientific background is a significant plus, given the highly innovative nature of our R&D efforts * Creative and flexible but also simultaneously able to keep the team's efforts disciplined, diligent, and on-time * Highly integrative thinker who understands and considers issues from an inter-disciplinary perspective * Performs well in an informal, dynamic, highly cross-functional culture (which places importance on strong teamwork and morale)

Keywords: HCPro, Inc., Cambridge , VP, Regulatory Affairs, Other , Cambridge, Massachusetts

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