Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Medical Director/Senior Director - Clinical Research

Biology & BiotechConfirmed live in the last 24 hours

Full-timeCambridge, MA, USA$250k - $350k /yr

About the Job

Requirements

An MD, MD/PhD, or equivalent is required, and the candidate must be based in greater Boston.
The candidate must be able to attend the Cambridge, Massachusetts office regularly.
At least 5 years of biopharmaceutical industry experience, including at least 3 years of clinical development experience, is required.
Experience designing innovative clinical studies, analyzing clinical data, preparing publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics are required.
The candidate must understand the drug development process from pre-IND through BLA.
Experience interacting with health authorities in the United States and European Union is required.
In-depth knowledge of ICH-GCP and other applicable regulatory guidelines is required.
The candidate must be able to travel domestically and internationally approximately 15%.
The candidate must be able to synthesize complex information and communicate effectively both verbally and in writing.
The candidate must be organized, outcome-oriented, self-motivated, and able to work collaboratively and manage conflict effectively.

Responsibilities

Provide medical leadership for clinical development activities of assigned pipeline products, including defining clinical development strategy and plans.
Collaborate with development and research team members to foster a collaborative culture and improve team effectiveness.
Serve as a subject matter expert by evaluating development strategies and plans, conducting literature reviews, assessing disease areas and development landscapes, and evaluating development and regulatory pathways.
Engage external scientific and clinical trial experts and clinical and regulatory consultants to develop scientifically robust clinical study designs.
Author clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, and publications.
Lead authorship of clinical responses to regulatory authorities concerning protocols, INDs, BLA/MAA/JNDA submissions, and other regulatory filings.
Provide medical leadership and input to cross-functional activities involving business development, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety.
Oversee clinical trials medically, including study medical monitoring, adverse event reporting, and patient safety across a development program.
Provide medical and scientific leadership in data analysis and interpretation while maintaining integrity, scientific rigor, and transparency.
Work in compliance with applicable GCP and ICH regulations.

Desired Qualifications

Experience in neuromuscular or rare disease areas is preferred but not required.

Salary Range: 250000 to 350000 (Currency: USD) (Pay period: per-year-salary)

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Summary of Position:

The (Senior) Medical Director, reporting to the VP, Clinical Research, will be a member of the clinical research team, accountable for driving clinical development activities for assigned pipeline products. The successful candidate will be responsible for providing medical leadership for clinical development activities in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing product candidates to deliver life-changing medicines.

Position Responsibilities:

Provide medical leadership for clinical development activities of assigned pipeline products, including leading efforts to define clinical development strategy and plan

Collaborate with other members of the development and research teams to contribute to building a collaborative culture and improving effectiveness of the development team

Serve as subject matter expert, leading efforts to provide scientifically robust evaluation of development strategy and plans, including robust literature review to perform disease area assessment, development landscape analysis, and development and regulatory pathway evaluation

Engage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust clinical study design

Provide hands-on authoring of clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, publications, etc.

Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filings

Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety

Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program.

Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency

Work within compliance to all applicable GCP/ ICH regulations

Candidate Requirements:

MD, MD/PhD, or equivalent, based in greater Boston

Ability to be present regularly in the Cambridge MA office

Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written

5+ years of experience in the biopharmaceutical industry, with 3+ years of clinical development experience; neuromuscular or rare disease experience preferred but not required

Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills

Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics

Understanding of the drug development process from pre-IND through BLA

Experience interacting with health authorities in the US and EU

In-depth knowledge of ICH-GCP and other application regulatory guidelines

Ability to travel domestically and internationally (~15%)

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

About the Company

Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Scholar Rock develops biopharmaceutical therapies by targeting protein growth factors to treat diverse diseases. Its work hinges on a proprietary drug discovery platform that identifies ways to modulate these growth factors, enabling creation of novel therapeutic solutions. The company advances its programs through research and development, and collaborates with other biopharmaceutical companies and research institutions, earning revenue via licensing agreements, milestone payments, and eventual product sales. Scholar Rock differentiates itself by focusing on protein growth factors and pursuing targets and indications that have been historically overlooked, with a strong emphasis on partnerships and patient-centric approaches. The overall goal is to deliver safe and effective therapies that improve patient outcomes by precisely modulating growth factor pathways through collaborative science.

Company size: 201-500
Company stage: IPO
Headquarters: Cambridge, MA
Founded: 2012

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