Senior Director, Toxicology

4 weeks ago

Brockton, Massachusetts, United States Insmed Incorporated 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 BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.



Overview

Overview The Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This position is located at our headquarters facility in Bridgewater, New Jersey.



Responsibilities

Responsibilities

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

Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules. Provide strategic direction on toxicology from discovery throughout market application for programs in different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards. Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy. Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents). Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution. Provide impurity safety assessment in support of CMC manufacturing and/or registration. Contribute to department SOPs and best practice documents. QualificationsDVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority. Proven track record of successfully leading toxicology programs through various stages of drug development. Experience in toxicology on biologics, oligonucleotides, and/or gene therapies is a plus. Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK. Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation. Passion for science with strong strategic thinking, critical thinking, and leadership skills. Agility to adapt to changes and flexibility to work across different time zones. Excellent interpersonal and communication skills.

Travel Requirements

Upto 5% travel



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 $170,000.00 to $236,667.00 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, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquarters

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 for 5 calendar days from the date posted or until the position is filled.

  • Senior Director, Toxicology

    1 month ago

    Brockton, Massachusetts, United States Insmed Incorporated Full time

    Company DescriptionInsmed 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...

  • Senior Director, Toxicology

    4 weeks ago

    Brockton, Massachusetts, United States Insmed Incorporated Full time

    Company DescriptionInsmed 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...

  • Director Toxicology

    1 month ago

    Brockton, Massachusetts, United States Insmed Incorporated Full time

    Company DescriptionInsmed 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...

  • Director Toxicology

    4 weeks ago

    Brockton, Massachusetts, United States Insmed Incorporated Full time

    Company DescriptionInsmed 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...

  • Senior Living Regional Float Director of Sales

    4 weeks ago

    Brockton, Massachusetts, United States Great Lakes Management Company Full time

    QualificationsBachelor's Degree; Business/Marketing/Communications, related field; Required3-5 Years of Related Experience; RequiredProficiency in Microsoft applications and database management; requiredResponsibilitiesHelp with onsite sales training, coaching and mentoring of current Senior Living Director of Sales.Monitors and ensures accountability for...

  • Senior Living Regional Float Director of Sales

    2 months ago

    Brockton, Massachusetts, United States Great Lakes Management Company Full time

    QualificationsBachelor's Degree; Business/Marketing/Communications, related field; Required3-5 Years of Related Experience; RequiredProficiency in Microsoft applications and database management; requiredResponsibilitiesHelp with onsite sales training, coaching and mentoring of current Senior Living Director of Sales.Monitors and ensures accountability for...

  • Senior Director

    4 weeks ago

    Brockton, Massachusetts, United States Daikin Applied Full time

    Make your mark at the world's largest HVAC company Why You'll Love Working for Daikin:We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential.Our goal is to "Perfect the Air". We do this through cutting edge innovation & sustainability...

  • Senior Director

    2 months ago

    Brockton, Massachusetts, United States Daikin Applied Full time

    Make your mark at the world's largest HVAC company Why You'll Love Working for Daikin:We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential.Our goal is to "Perfect the Air". We do this through cutting edge innovation & sustainability...

  • Senior Director

    1 month ago

    Brockton, Massachusetts, United States Daikin Applied Full time

    Make your mark at the world's largest HVAC company Why You'll Love Working for Daikin:We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential.Our goal is to "Perfect the Air". We do this through cutting edge innovation & sustainability...

  • Senior Director

    4 weeks ago

    Brockton, Massachusetts, United States Daikin Applied Full time

    Make your mark at the world's largest HVAC company Why You'll Love Working for Daikin:We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential.Our goal is to "Perfect the Air". We do this through cutting edge innovation & sustainability...

  • Senior Director of Software Engineering, New Product Introduction

    3 weeks ago

    Brockton, Massachusetts, United States Philips Full time

    Job TitleSenior Director of Software Engineering, New Product IntroductionJob DescriptionAs a key member of the Image Guided Therahy-Devices (IGT-D) R&D management team the Senior Director of Software Engineering, NPI leads a global R&D team and drives full product development lifecycle of clinical application and our SW platform architecture. Your role:...

  • Director of Sales and Marketing

    1 week ago

    Brockton, Massachusetts, United States Distinctive Living Full time

    Welcome to Distinctive Living, we're seeking a Director of Sales and Marketing (Full-Time) for our Senior Living Community, Mira Vie at Green Knoll. Here at Distinctive Living, we want our people to realize their full potential. We're passionate about personal and professional growth and will do everything we can to help you flourish. We deeply care about...

  • Executive Director

    1 month ago

    Brockton, Massachusetts, United States Great Lakes Management Company Full time

    Join Our Team as an Executive DirectorAre you passionate about seniors and assisted living? Do you thrive in a leadership role where you can inspire and empower others to reach their full potential? If so, we want you to be a part of our dynamic team at Great Lakes ManagementWhy Join Us?At Great Lakes Management, we're dedicated to creating a positive...

  • Director of Nursing 20247501BRK

    1 week ago

    Brockton, Massachusetts, United States Brockton Area Multi-Servi Full time

    Job DescriptionJob DescriptionBAMSI is hiring a Nurse Director for our Brockton Programs[40 Hours] - Schedule: Mon-Fri 9a-5p $100k Yearly SalaryGeneral Statement of Duties: Oversee the health care needs of individuals living in assigned residential programs. The Nursing Director provides clinical support and supervision to the nursing staff and works...

  • Director of Finance

    1 month ago

    Brockton, Massachusetts, United States Saint John's Resort Full time

    Director of Finance – HospitalitySuburban Detroit Hotel/Golf/Conference Center is seeking a Director of Finance. This is a highly visible position that will work closely with Senior Management, Mid-level Management and Ownership. Besides full responsibility for the day-to-day accounting activities of the Complex, this position will require close work with...

  • Director of Finance

    4 weeks ago

    Brockton, Massachusetts, United States Saint John's Resort Full time

    Director of Finance – HospitalitySuburban Detroit Hotel/Golf/Conference Center is seeking a Director of Finance. This is a highly visible position that will work closely with Senior Management, Mid-level Management and Ownership. Besides full responsibility for the day-to-day accounting activities of the Complex, this position will require close work with...

  • Director of Youth Ministries at Dayton and

    1 week ago

    Brockton, Massachusetts, United States Bridgewater United Methodist Church Full time

    Director of Youth Ministries at Dayton and Bridgewater UMC(Combined Youth Group DUBUM)Job Description (Updated 5/30/2024)STATUS:Part-timeHOURS:25 Hours per weekSALARY:$10,400/year per church or $20,800/year totalSummary: Dayton United Methodist Church (DUMC) and Bridgewater United MethodistChurch (BUMC) are seeking a Director of Youth Ministries (DYM) for...

  • Sr. Director of Housing Services

    1 week ago

    Brockton, Massachusetts, United States Father Bill's & MainSpring Full time

    Job Description Job Description Position Summary:The Senior Director of Housing Services role will oversee all permanent supported housing services and housing administration functions that FBMS manages across Southern Massachusetts, spanning over 40 communities. This individual will lead the response to homelessness with an emphasis on stabilization,...

  • Stem Director

    1 week ago

    Brockton, Massachusetts, United States Boys & Girls Clubs of Metro South Full time

    The STEM Director will be a dynamic youth development professional and will provide Club-wide support of STEM programs at our Brockton Clubhouse through the coordination, development, and delivery of curriculum and activities. This role collaborates, at all levels of the organization, to ensure high-quality programming is being delivered consistently and...

  • Associate director of operations

    1 week ago

    Brockton, Massachusetts, United States Father Bill's & MainSpring Full time

    Father Bill's & MainSpring (FBMS) is seeking anexperienced fundraising professional, with strong project management skills, tomanage activities related to FBMS' annual fund, with the goal to raise approximately $2M annually. This position is part ofthe Development Leadership team, working in collaboration with the ChiefDevelopment Officer, Senior Director of...