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Associate Scientific Director, Pharmacometrics

Role overview

Qualifications

  • PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline.
  • 5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision making.
  • Deep and extensive experience with advanced population PK/PD methodology.
  • Strong understanding of the clinical pharmacology principles and methodologies and their application in drug development.

Responsibilities

  • Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams.
  • Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs.
  • Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety.
  • Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design.

Key facts

Other skills

  • Decision Making
  • Collaboration
  • Mentorship
  • Communication

About the company

Biogen logo

Biogen

Biotechnology

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Company details

Company typeXLarge
IndustryBiotechnology
Company size5001 - 10000

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Job description

About This Role

Pharmacometrics analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value at Biogen.  As the Associate Director, Pharmacometrics, you will provide pharmacometrics expertise for high-priority clinical development programs and support quantitative decision-making through advanced modeling and simulation.

In this role, you will contribute to the pharmacometrics strategy across disease areas and serve as a key scientific resource to program teams and functional partners. You will report to the Head of Pharmacometrics and collaborate closely with cross functional teams to ensure pharmacometrics analyses are appropriately applied to program needs.

What You’ll Do

  • Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams  
  • Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs
  • Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety
  • Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design
  • Communicate the pharmacometrics analysis results to program teams to support data-driven decision-making process
  • Mentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologies
  • Serve as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documents
  • Publish in scientific journals and present at internal and external scientific events

Who You Are

 You are a quantitative scientist with strong experience applying population PK/PD analysis methodology to drug development questions. You are comfortable working on complex problems, contributing scientific insight to multidisciplinary teams and supporting program-level decision-making through rigorous quantitative analyses.

 #LI-TD1

Qualifications

Required Skills

  • PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline.
  • 5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision making
  • Deep and extensive experience with advanced population PK/PD methodology
  • Strong understanding of the clinical pharmacology principles and methodologies and their application in drug development
  • Solid knowledge of the drug development process and regulatory expectations for pharmacometrics analyses
  • Ability to interpret quantitative results and translate analyses into actionable program insights
  • Hands-on experience with pharmacometrics software tools such as NONMEM, Monolix, and R.
  • Experience with mechanistic or systems pharmacology models is a plus.


 

Job Level: Management


Additional Information

The base compensation range for this role is: $167,000.00-$230,000.00


Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.


Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. 


In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement 
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance 
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit 
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan 
  • Tuition reimbursement of up to $10,000 per calendar year 
  • Employee Resource Groups participation

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 Biogen.


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.

 

 

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