Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Scholar Rock
Cambridge, MA, United States
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structur
Job Source: Scholar RockIntellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia Therapeutics, Inc.Intellia Therapeutics
Cambridge
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia TherapeuticsMythic Therapeutics
Waltham, MA, United States
Company Overview: Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company's FateControl™ engineering technology dramatically enhances ADC uptake in tumor cells with less
Job Source: Mythic TherapeuticsVeeva Systems, Inc.
Boston, MA, United States
Strategy Director - Pharmacovigilance/Safety (Enterprise) Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahe
Job Source: Veeva Systems, Inc.Veeva Systems, Inc.
Boston, MA, United States
Strategy Director - Pharmacovigilance/Safety (SMB) Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At
Job Source: Veeva Systems, Inc.Dyne Therapeutics Inc
Watertown, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle
Job Source: Dyne Therapeutics IncThe Elle Group
Boston, MA, United States
The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a saf
Job Source: The Elle GroupCambridge, MA, United States
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative and experienced team. Playing a critical role within Scholar Rock, the Medical Director, Safety & Pharmacovigilance will be responsible for strategic medical leadership for global pharmacovigilance and risk management activities for Scholar Rock developmental candidates. This position requires a highly motivated and enthusiastic medical professional with hands-on expertise in taking novel compounds from clinical candidate nomination through proof-of-concept and beyond. Key success factors for the position include rare disease, cardiometabolic disease or immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a 'hands-on doer.'
Position Responsibilities:
Leads and directs all aspects of pharmacovigilance activities for assigned investigational products including signal detection, analysis, communication, and mitigation of potential safety risks
Provides medical and pharmacovigilance expertise to lead decision making based on ongoing benefit-risk assessment, pharmacoepidemiologic or clinical trial data interpretation, and risk evaluation and mitigation
Authors, reviews, and provides input for drug-safety related regulatory reports and clinical study documents including periodic aggregate reports, case series analyses, and regulatory submission documents
Contributes to the development of internal processes including SOPs, Policies and Work Instructions
Willingly support other activities as needed
Candidate Requirements:
MD required, combined with 5 to 10 years of experience in pharmacovigilance and clinical safety
Clinical experience with patients following post-graduate training is an asset
Knowledge of principles of epidemiology and statistics
Critical thinking, analytical skills and ability to make high level decisions
Proven history of successful involvement in Regulatory submissions, IND and/or BLA / NDA.
History of successful interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for biologics
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
Email Alert for Medical Director, Safety & Pharmacovigilance jobs in Cambridge, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.