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.
Named Science's Top Employer in 2021 and 2022
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 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.
This role represents the Translational Bioanalytical Sciences (TBS) group as it related to Biomarker, Biologics and Gene Therapy products in advance of and during human clinical trials. This role resides within Clinical Development organization, works closely with colleagues in other functions, including strategic interactions with multiple Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate to TBS.
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Establish and direct biotherapeutic bioanalytical assay development for PK, ADA, PD, Biomarker and Nab assays for small and large molecule therapeutics as well as support of other modalities such as gene therapies platforms.
- Assure bioanalytical tasks are executed to high scientific standards, with quality, and within agreed timelines. This entails overseeing work by internal facilities or external vendors, within a matrix-structured environment. No bench activities are expected from this role.
- Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs
- Accountable for the scientific guidance and design of the bioanalytical translational and clinical strategies and the execution (e.g. Immunogenicity and Biomarker) of therapeutic programs with different modalities.
- Participate in clinical study design and documentation (lab manual, protocol, report, SAP).
- Participate in preclinical study design and documentation as needed.
- Contribute to regulatory document writing (e.g. IB, IND, Integrated Summary of Immunogenicity).
- Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA).
- Manage customized bioanalytical assays via network of external service providers in advance of and during clinical development.
- Participate in vendor governance.
- Identify, evaluate and manage bioanalytical vendors, partnering with the Procurement function.
- PhD in Immunology, Molecular Biology, Biochemistry or another relevant field.
- Minimum of 8+ years' post-doctoral experience in the pharmaceutical, CRO or related industry within bioanalytical area across various modalities.
- Fundamental understanding of immunogenicity assay development and validation. Ability to assist with LBA method troubleshooting across a variety of platforms. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data.
- Strong understanding and experience with relevant quality systems (GLP, GCLP, GCP etc.)
- In-depth working knowledge of various assay platforms used to develop and to validate assays needed for clinical development trials.
- Previous hands-on experience with the development of ligand binding assays as well as some experience with qPCR techniques and cellular assays preferred (ex. Flow Cytometry assays, Receptor occupancy assays, Cellular Immunogenicity assays).
- Strong communication skills (verbal and written) and presentation skills are required.
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment.
Up to 10% travel, both domestic and/or international travel based on vendor requirements. 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 $140,000.00 to $200,000.00 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:
ADDITIONAL U.S. BENEFITS:
- 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).
- 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
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.
Please note that we review every submission, and we will keep all submissions on file for six months.
This job has expired.