Sr Director, DSPV Medical Safety

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Job description

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Consistently Ranked Science's Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.

Overview

The Senior Director is the DSPV medical expert for assigned products and maintains current knowledge of assigned product portfolio and safety profiles for products. This individual will be responsible for the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are successfully completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, you will be responsible, globally, for executing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customers. This position reports to the Executive Director (ED), DSPV and will provide coverage for the ED, DSPV during his absence. Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Leads strategic consultation, and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed's portfolio of products in development. Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds
• Responsible for the delivery of high quality and timely medical safety deliverables. Provides content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
• Leads the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
• Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Works with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Responsible for key content of Risk Management documents (RMPs, REMS) of assigned products.
• Responsible for the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports.
• Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Provide expert safety input to the clinical development program for assigned products and development compounds
• Leads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator Brochure and Risk Management Plans (RMPs) and Risk-Evaluation and Mitigation Strategies (REMS).
• Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
• Responsible for preparing responses to inquiries from regulatory authorities on safety issues for assigned products. Leads the integrated safety input into all regulatory documents where required
• Perform thorough assessment of safety profiles for Due Diligence project
• Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
• Perform the medical review of all adverse event reports for seriousness, expectedness and causality
• Maintain and evaluate Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, and creating an action plan and communicating metrics to appropriate teams and individuals. Identifies concerns and champions issue resolution.
• Oversee medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsource to vendors and contract research organizations (CROs).
• Participates in the evaluation, monitoring, and oversight of strategic drug safety company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and that safety-related project milestones are met within required timelines.
• Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports.
• Ensures audit and inspection readiness of the function at all times.
• Other related responsibilities and duties, as required by business need and/or assigned.

Job Requirements:

• M.D. or D.O. (US or Internationally trained) preferred; MPH (Masters of Public Health) is a plus.
• At least 2 years of Clinical Patient Care experience preferred.
• At least 8 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products.
• At least 5 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.
• Ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information.
• Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Providing product defense before a national or international regulatory authority a plus.
• Must have excellent communication skills (verbal and written).
• Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired.
• Experience in drug development, clinical trial methodology. Rare disease experience preferred.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
• Experience in responsible/leading roles in clinical or safety through complete submission process.
• Experience in presenting clinical or safety data to major health authorities.
• Strong leadership skills including coaching, motivating, and directing, and fostering teamwork.
• Experience in leading cross-functional, multi-cultural teams. Ability to develop and maintain effective working relationships with subordinates, superiors, and peers.
• Strong negotiation and conflict management skills.
• Drug safety database knowledge preferred.
• Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills.

Travel Requirements:

• Up to 20% travel both domestic and international.

Travel Requirements

• Up to 20% travel both domestic and international.

Salary Range

$283,000 - $339,000 a year Compensation & Benefits
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