Senior Clinical Pharmacology Specialist
- Employer
- Novo Nordisk
- Location
- Lexington, MA
- Start date
- Nov 11, 2024
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- Discipline
- Clinical, Clinical Medicine, Clinical Research
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
About the Department
Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. Our Novel Modality department covers development of treatment modalities such as siRNAs and multiclonal antibodies across multiple therapy areas within the cardiometabolic and rare disease spectrum. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development 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. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference
The Position
The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s), Dosage and administration strategy, including dose setting and dosing regimen for project(s), Scientific and pharmacology aspects of trials in the clinical development program and knowledge-sharing as expert in clinical pharmacology, PK/PD, dosage and administration. This role is highly cross-functional and may involve some travel.
Relationships
Reports to the Senior Director, Clinical Pharmacology for the U.S. East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory, Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science.
Essential Functions
- Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s)
- Develop clinical pharmacology strategy for project(s) and align with Global Project Team(s) (GPT), Medical & Science Team(s) (MST) (if applicable), and line of business
- Responsible for clinical pharmacology strategy in the Product Development Plan
- Responsible for designing the clinical pharmacology trials to match strategy
- Ensure scientific quality of Clinical Pharmacology Summary and other documents with clinical pharmacology such as Investigator’s Brochure and Health Authorities interactions in line with strategy
- Attend and negotiate clinical pharmacology aspects at internal and external meetings with e.g. regulatory authorities /advisory board meetings / governance boards / investigator meetings / safety committees according to strategy
- Scientific and pharmacology aspects of trials in the clinical development program
- Scientifically responsible for clinical pharmacology protocol outline/protocol(s)
- Ensure scientific quality, model informed drug development and innovation in clinical pharmacology trials
- Ensure trial design is aligned with overall clinical pharmacology and dosing strategy
- Ensure appropriate cost/benefit of planned assessments and align with the needs of relevant stakeholders
Physical Requirements
Ability to travel occasionally – both internationally (our headquarters are located in Denmark) and domestically in the U.S.
Qualifications
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.
CONNECT
- Website
- https://www.novonordisk-us.com/
- Phone
- 617-612-6200
- Location
-
75 Hayden Avenue
Lexington
MA
02421
United States
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