Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Senior Medical Director - Drug Safety & Pharmacovigilance

Biology & BiotechConfirmed live in the last 24 hours

Full-timeCambridge, MA, USA$280k - $420k /yr

About the Job

Requirements

A medical degree: MD, MBBS, MD-PhD, or equivalent.
At least 5 years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
Strong understanding of pharmacovigilance regulations in the United States and European Union.
Experience supporting drug safety activities in registrational clinical studies.
High medical competence and the ability to balance it with industry standards to achieve business goals.
Demonstrated scientific analysis and reasoning skills.
Sound knowledge of the drug development process from discovery through registration, post-marketing requirements, and surveillance.
A strong track record of delivering results through effective team and peer leadership in a matrix environment.
Strong leadership, organizational, analytical, and presentation skills, including experience translating important data into clinical strategies.
Ability to build effective working relationships, influence, negotiate, drive organizational engagement, and adapt to changing organizational needs.

Responsibilities

Lead and support development of pharmacovigilance strategies for products within the therapeutic area, ensuring alignment with corporate clinical development and commercial goals.
Oversee and conduct signal detection activities, including monitoring, evaluation, interpretation, management, and communication of safety information.
Oversee and conduct Product Safety Committee meetings to evaluate compound risk-benefit with cross-functional support, and escalate and present safety issues to the Executive Safety Committee.
Conduct medical safety reviews, including causality assessments of available pre-clinical, clinical trial, post-marketing, and literature safety data throughout development for assigned compounds and projects.
Provide medical expert safety review input into critical clinical development documents, including IND, NDA, and BLA submissions, protocols and amendments, informed consent forms, investigator brochures, and clinical research reports.
Oversee aggregate reports and signal evaluation reports for assigned projects.
Own clinical content of responses to regulatory authority inquiries related to safety topics.
Provide leadership and support to Contract Research Organization staff to ensure service delivery, and oversee outsourced medical activities as applicable.
Oversee and collaborate with internal safety scientists within the therapeutic area.
Assist with writing and developing standard operating procedures as required to ensure compliance with regulations and local laws.
Lead planning and execution of external and internal stakeholder meetings, including Data Monitoring Committee and vendor oversight meetings.
Support process improvement and functional training at department and company levels.
Demonstrate high quality, ethical, and professional values in all work.
Ensure compliance with corporate policies and procedures and applicable healthcare laws and regulations.

Desired Qualifications

Prior IND and NDA/BLA filing or submission experience, and other regulatory interaction experience, is highly desirable.

Salary Range: 280000 to 420000 (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 Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.

Position Responsibilities:

Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information.
Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee.
Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
Oversight of aggregate reports and signal evaluation reports for assigned projects.
Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable.
Oversee and collaborate with internal safety scientists within TA
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.
Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
Support process improvement and functional training at departmental & company level
Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work.
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations

Candidate Requirements:

MD or MBBS or MD-PhD or equivalent medical degree
5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
Strong understanding of pharmacovigilance regulations in the US and EU.
Experience in supporting drug safety activities in registrational clinical studies
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
Demonstrated skills in scientific analysis and reasoning.
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
Strong track record of delivering results through effective team and peer leadership in matrix
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.

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

Recently Posted Jobs

Explore more opportunities at Scholar Rock

See more jobs