Job Description
This application is for a 6-month student role from January - June 2025. Resume review begins in October 2024.
Clinical Pharmacology is a major component in drug development contributing approximately 80% of the patient's guidance and package insert. Therefore, it is important to have a trained clinical pharmacologist with sound knowledge/experience in developing clinical pharmacology package including design and implementation of clinical pharmacology studies. Extrapolation of clinical response is an important aspect in the pediatric drug development, especially in rare disease area where prevalence of pediatric population is very rare. It is desirable to have a clear understanding of the latest regulatory guidance on extrapolation in pediatric drug development and opportunities in rare disease area. Thorough research in this area and possible implementation opportunities of that in the pediatric development of Biogen products will benefit the organization.
Position Description
As a co-op, you will:
- Learn and implement the regulatory guidance of conducting clinical pharmacology studies
- Support Clinical Pharmacology and Pharmacometrics (CPP) lead to develop at least one clinical pharmacology study protocol and day to day operation of the study.
- Develop a summary based on literature search of extrapolation approaches utilized in clinical development, both pediatric and adult indication
- Provide a graphical and/or tabulator summary of the results. An internal presentation is highly encouraged (audience: CPP team)
- Explore development/support of disease progression model for Friedreich's ataxia
- Prepare external poster and manuscript publications, when applicable.
This work might be expanded to other indications and populations if time allowed.
Qualifications
Include the knowledge, skills, and abilities you may be seeking.
- Pharmacology/Pharmacometrics related knowledge is required.
- NONMEM and R experience is preferred. Experience with PsN or similar M&S tools is strongly preferred.
- Ability to design clinical pharmacology studies and analyze PK/PD data utilizing sound scientific principles.
- Excellent oral and written communication skills
To participate in the Biogen Internship Program, students must meet the following eligibility criteria:
- Legal authorization to work in the U.S.
- At least 18 years of age prior to the scheduled start date
- Be currently enrolled in an accredited community college, college or university
Education
- PhD candidate or Post Doc is preferred.
- PharmD candidate with strong background can be considered.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
