Director, Clinical Pharmacology
2 weeks ago
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 Director of Clinical Pharmacology role within Clinical Development organization will provide leadership and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding portfolio of small, biological and inhaled molecules across several disease areas. The clinical pharmacologist will be responsible and accountable for designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring summary and regulatory submission documents. The clinical pharmacologist will work in collaboration with various stakeholders in a cross-function team environment and provide oversight to external vendors.
Responsibilities:
ResponsibilitiesFunction as a Clinical Pharmacology lead supporting assigned programs in clinical development
Lead and design clinical pharmacology studies and provide clinical pharmacology support to late phase clinical studies
Plan, perform, and/or oversee PK, PK/PD and pharmacometric analyses for clinical and non-clinical studies
Apply model-based drug development strategy to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissions
Author regulatory summary documents, such as briefing documents, IND, NDA, etc., and provide responses to world-wide regulatory authorities for the clinical pharmacology related inquiries
Preparation of abstracts and manuscripts for publication
Closely partner with Research, Clinical teams, Bioanalytics, Regulatory, Project Management, and other R&D functions
Provide oversight to external vendors for pharmacometrics, modeling and simulation and DMPK related studies
QualificationsPhD in Pharmacokinetics, Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience
Minimum of 7 years of experience in pharmaceutical industry
Solid working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology
Thorough understanding of overall drug development programs and familiar with clinical pharmacology related regulatory guidelines.
Hands-on and Working knowledge of population PK, PBPK, PK/PD modeling are highly desirable.
Hands-on capability for data visualizations software is required.
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 are essential.
Travel Requirements:
Minimal 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 $(phone number removed) to $(phone number removed) 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 based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid vacation schedule and winter break
ADDITIONAL U.S. BENEFITS:
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-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.
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