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Executive Director, DSPV Medical Safety

4 months ago

Bridgewater, United States Insmed, Inc. Full time

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

Named Science's Top Employer in 2021, 2022, and 2023

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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, and Best Workplaces for Millennials lists.

Overview

The Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the day-to-day direction to 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, the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to the VP, DSPV and will provide coverage for the VP, DSPV during his absence.

Responsibilities

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

* Provides oversight, strategic consultation, and guidance to the Medical Safety Leads 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 and on the market.
* Accountable for the delivery of high quality and timely medical safety deliverables. Provides content guidance and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee.
* 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).
* 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. Develops Safety Management Plans.
* Directs the compilation and interpretation of safety data for reporting purposes, including marketing applications to regulatory agencies, in collaboration with Clinical Development. Closely supervises major written deliverables (all regulatory submissions [NDA/MAA safety sections and reference safety information/CCDS, PSUR/PBRER, DSUR], original articles, abstracts), and presentation materials.
* Drives the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments and Risk Management Plans (RMPs) and Risk-Evaluation and Mitigation Strategies (REMS).
* Responsible for preparing responses to inquiries from regulatory authorities on safety issues for assigned products; provides content guidance and functional approval for regulatory responses for other Medical Safety Leads.
* 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 partners, CROs, professional consultants, and /or contractors to ensure compliance with 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.
* Contributes to the organizational planning, budget, and operations of DSPV.
* Ensures audit and inspection readiness of the function at all times.
* Prepares safety objectives, and evaluates and manages performance of the DSPV Medical Safety Team.
* Participates in building the talent pipeline for key roles in Medical Safety and DSPV.
* Other related responsibilities and duties, as required by business need and/or assigned.

Qualifications

* Medical degree required. Specialty Board Certification desirable. Useful additional degrees: Post-graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) strongly preferred.
* A minimum 4 years of postdoctoral clinical experience required.
* At least 10 years in drug development in a biotech or pharmaceutical company, including a minimum of 8 years in a safety-related position.
* 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.

Travel Requirements

Domestic and/or International travel required 15%

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $319,000.00 to $382,600.00 per year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

* Flexible approach to where and how we work
* Competitive compensation package including bonus.
* Stock options and RSU awards
* Employee stock purchase plan
* 401(k) plan with company match
* Professional Judgment Vacation Policy
* 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

* Medical, dental, and vision plans
* Company-provided short- and long-term disability plans
* Company-provided life insurance
* Unique offerings of pet, legal, and supplemental life insurance
* Flexible spending accounts for medical and dependent care
* Accident and Hospital Indemnity plans
* Supplemental AD&D
* Employee Assistance Program (EAP)
* Mental Health on-line digital resource
* On-site, no-cost fitness center at our U.S. headquarters
* Paid time off to volunteer

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Applications are accepted until the position is filled.