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Associate Director Translational Bioanalytical
4 months ago
Company Description:
**About Insmed**
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.- Lead projects, provide oversight of outsourced GxP bioanalytical validations and sample analysis from early to late development for pharmacokinetic and biomarkers studies.
- Accountable for the scientific guidance and design of the bioanalytical translational and clinical strategies and the execution (e.g. Biomarker) of therapeutic programs with different modalities.
- 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.
- Provide technical expertise on sample preparation, chromatography, mass spectrometric instrumentation, stability, and other method related issues.
- 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.
- 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.
Travel Requirements:
up to 10%
**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:
**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 fe
