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Clinical Pharmacology Specialist

Employer
Novo Nordisk
Location
Lexington, MA
Start date
Apr 20, 2024

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Job Details

About the Department                                                                                                                                             

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources,and stability, uniting the best of both worlds to develop new medicines for patients.

 

The Position

East Coast Hub (ECH), Novo Nordisk, focused on the development of innovative treatments for rare diseases, blood diseases, chronic liver diseases, cardiovascular disease, and viral liver infectious diseases. The Clinical Pharmacology Specialist will be responsible for all aspects of the clinical pharmacology strategies including early (Phase 1) and late-stage development (Phase 2/3 and NDA filings). This individual will provide strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate in selected preclinical and all clinical areas.

 

This person, in collaboration with other stake holders, will also provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.

 

Relationships

Reports to the Vice President of Medical & Science.

 

Essential Functions

  • Scientific responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology-related aspects of all interventional clinical studies
  • Develop and execute clinical pharmacology strategies in collaboration with internal and external partners to advance drug candidates in an efficient and scientifically rigorous manner
  • Lead cutting edge science, creativity, and novel approaches in clinical pharmacology and related areas
  • Oversee Clinical Pharmacology activities conducted by CROs
  • Represent clinical pharmacology in project teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies
  • Will have a key role to play in influencing development programs using model-informed quantitative approaches, exposure-response) to evaluate risk/benefit and facilitate drug development decisions
  •  

    Physical Requirements

    0-10% overnight travel required.

     

    Qualifications

  • Master Science or above in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics
  • 3+ years of relevant experience in drug development
  • Must demonstrate the aptitude and experience to be a specialist in Pharmacometrics and clinical pharmacology
  • Experience in formulating and executing clinical development strategies including design, interpretation and reporting of clinical pharmacology studies is required
  • A working knowledge and previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PKPD data management/analysis,population modeling and simulations and experimental medicine is also needed
  • Broad familiarity with the drug development process is highly desirable as is prior experience working with CROs
  • Excellent interpersonal and communication skills, both written and oral, are essential to perform in this matrixed and highly collaborative environment
  •  

    The base compensation range for this position is $[ ] to $[ ]. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. 
     
    Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. 
     
    Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

     

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

     

    If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    US

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