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    Senior Clinical Pharmacology Specialist

    Novo Nordisk
    2+ years
    Not Disclosed
    Lexington
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Pharmacology Specialist

    Location: East Coast Global Development Hub, Novo Nordisk
    Facilities: Lexington, MA, and Plainsboro, NJ

    About the Department

    Our East Coast Global Development Hub unites the best minds in life science innovation, operating with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. Our Novel Modality department focuses on the development of treatment modalities such as siRNAs and monoclonal antibodies across a broad range of therapeutic areas, including cardiometabolic and rare diseases. The hub combines biotech speed and large pharmaceutical company stability to deliver new medicines for patients, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research. We’re changing lives for a living. Are you ready to make a difference?

    The Position

    As a Clinical Pharmacology Specialist, you will be responsible for developing and executing clinical pharmacology strategies for phases 1-4 of Clinical Development programs. This will involve overseeing the dosage and administration strategy, including dose setting and dosing regimens. You will also contribute to the scientific and pharmacology aspects of clinical trials, ensuring they align with overall strategies. The role is cross-functional and may involve occasional travel.

    Key Responsibilities

    Clinical Pharmacology Strategy

    • Develop and align clinical pharmacology strategies for assigned projects, in collaboration with the Global Project Team (GPT), Medical & Science Teams (MST), and relevant stakeholders.
    • Ensure scientific quality of clinical pharmacology documents such as Clinical Pharmacology Summary, Investigator’s Brochure, and Health Authorities interactions.
    • Attend and contribute to regulatory authorities, advisory board meetings, and other internal/external meetings to negotiate pharmacology aspects.

    Dosage and Administration Strategy

    • Develop dosage and administration strategies and ensure alignment with project teams and business objectives.
    • Maintain an overview of PK/PD properties, CMC activities, and other relevant studies to support dose setting.
    • Ensure appropriate trial design is aligned with pharmacology and dosing strategies.

    Trial Design and Scientific Oversight

    • Design and oversee clinical pharmacology protocols ensuring scientific rigor and innovation in trials.
    • Support the scientific aspects of clinical trial applications and facilitate interactions with investigators.
    • Take responsibility for the assessment, evaluation, and interpretation of scientific data until the completion of trial reporting.

    Knowledge Sharing and External Engagement

    • Continuously develop your own expertise in clinical pharmacology, PK/PD, and dosing aspects in relation to assigned projects.
    • Prepare publications and engage in knowledge sharing within the clinical pharmacology team and with relevant external stakeholders.
    • Maintain relationships with investigators, key opinion leaders, and research scientists in the field.

    Physical Requirements

    • Occasional travel, both domestically and internationally (headquarters located in Denmark).

    Qualifications

    Education

    • PhD with 0-2 years of experience, or PharmD with 2+ years of experience, or Master’s degree with 5+ years of relevant experience in clinical pharmacology or a related field.

    Experience

    • Expert knowledge in clinical pharmacology and PK/PD.
    • Solid experience with strategic planning of clinical development in the pharmaceutical industry.
    • Expertise in managing clinical pharmacology projects, and knowledge of trial designs in clinical pharmacology.
    • Experience in drug development and familiarity with clinical trial methodologies.
    • Relevant therapeutic area knowledge is a plus.

    Equal Opportunity Employer

    Novo Nordisk is committed to creating an inclusive and diverse culture, and we celebrate the diversity of our employees, patients, and communities. We are an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

    If you require assistance or an accommodation to apply, please call 1-855-411-5290.

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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    Warsaw |

    Remote :

    Zaragoza | Melbourne | Faridabad | Texas | Bountiful | McFarland | Hammond | Remote - Middle East | Blue Bell | Hungary | Riga | Remote - South America (Latin Americal) | Springville | Victoria | French | Minnesota | Xzagreb | Remote - Europe | Medan | Bishop | Lousiana | Ireland | Nairobi | Remote | Remote - Africa | Lenexa | Green Way | Belgium | Switzerland | Castlebar | Thailand | Slovakia | Tulsa | Manipal | Leinster | Remote, USA |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Khulais | King Abdullah Economic City | Jeddah | Riyadh | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |