Sr. Medical Director, Drug Safety & Pharmacovigilance

Scholar Rock; Cambridge (MA); Presencial; USD 280 000 - 420 000; Tempo integral

Resumo da oferta

A biopharmaceutical company seeks a Sr. Medical Director in Drug Safety & Pharmacovigilance in Cambridge, MA. This pivotal role requires an MD or equivalent degree and entails leading safety strategy and compliance efforts for drug development. Responsibilities include overseeing signal detection, conducting medical safety reviews, and ensuring adherence to regulations. Candidates should have over 5 years of experience in pharmacovigilance with a strong grasp of US/EU regulations. Competitive salary between $280,000 - $420,000 based on experience.

Qualificações

• 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• High level of medical competence with the ability to balance it with industry standards.
• Prior IND and NDA/BLA regulatory interaction experience is highly desirable.

Responsabilidades

• Lead and support development of pharmacovigilance strategies.
• Oversight of signal detection activities, managing safety information.
• Responsible for oversight of Product Safety Committee meetings.

Conhecimentos

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

Leadership and organizational skills

Scientific analysis and reasoning

Formação académica

MD or MBBS or MD-PhD or equivalent medical degree

Descrição da oferta de emprego

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 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

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 withcorporate clinical development and commercial goals.
• Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management andcommunication of safety information.
• Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for thecompounds with support from cross-functional teams. Escalate and present safety issues tothe Executive Safety Committee.
• Medical safety review including causality assessment of all available safety data generated from varioussources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the developmentprocess for assigned compounds/projects.
• Provides medical expert safety review input into all critical documents for products in clinicaldevelopment (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinicalresearch 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 toSafety topics.
• Provide leadership and support to Contract Research Organization (CRO) staff to ensure overalldelivery 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.

$280,000 - $420,000 a year

Equal Opportunity Employer

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