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Scientist II, Pharmacometrics
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitleScientist II, Pharmacometrics
Job DescriptionThe Sr Pharmacometrician / Associate Director, Clinical Pharmacology and Pharmacometrics serves as the Clinical Pharmacology and Pharmacometrics lead on early program teams providing strategic leadership and execution of Quantitative Pharmacology plans that include characterization of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) of the drug candidate. This person also executes and/or oversees development and application of Quantitative models, providing rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment should be considered.

- Responsible for providing key components of the Early Development Plan (strategy/analysis through final reports) and for providing input and scientific opinion to project teams, line management, and governance bodies.
- Leads Clinical Pharmacology and Pharmacometrics study efforts (eg, study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD/DM insight for future critical decisions. Analyzes results, interprets, and recommends action based on study results.
- Works with Clinicians, Quantitative Sciences and DMPK/PD to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.

- Works with study and program teams to achieve program goals and provide deliverables in approved timeframes.
- Identifies program and study-specific issues. Generates potential solutions to issues and proposes those solutions to management and/or study teams.

- Utilizes Advisory Board members, Thought Leaders, and Academic Collaborators as necessary to add effective value to our development programs.
- Develops and maintains strong knowledge of best regulatory practices, analytical technology and drug development precedent for Clinical Pharmacology and Pharmacometrics.
- Provides regulatory strategy and is responsible for Clinical Pharmacology and Pharmacometrics sections of regulatory documents.

LocationCambridge, MA, US
Job CategoryResearch
Requisition Number30235BR
Qualifications- Employs continuous improvement in knowledge and practical understanding of Mechanistic/Systems Pharmacology, PPDM, Clinical Pharmacology and Pharmacometrics and application of this knowledge in the program team setting.
- Understands and is able to apply appropriate regulatory and ICH guidelines in the design of all studies.
- Can manage a diverse, time-sensitive workload.
- Possesses strong English communication skills requiring minimal oversight in drafting grammatically correct written documents and making oral presentations.
- Has excellent organization and interpersonal skills.
Education- Ph.D., M.D./Ph.D., or Pharm.D. in biomedical engineering, applied pharmacology, pharmacokinetics, or a related field.
- 4+ years of direct industry experience in Clinical Pharmacology and Pharmacometrics , advanced modeling & simulation, and program team support.
- Some experience in drafting early drug development strategy and designing/implementing studies for multiple compounds including PPDM data analyses for both biologics and small molecules.
- Demonstrates a strong understanding of: 1) PK/PD principles, physiology/pharmacology and pathology; 2) operational and scientific aspects of early development studies; and 3) quantitative analysis.
About BiogenCorporate Overview
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), 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 (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
  • Biogen was founded in 1978 and today serves patients in nearly 70 countries.
  • A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion
  • Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland
Our Science
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
  • For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
  • We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer's disease, Parkinson's disease, and ALS.
  • As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
  • Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.
Our Corporate Citizenship
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

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.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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