About the Department
The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?
This role will contribute to the organization's goals by providing Clinical Pharmacology expertise for new drugs in all clinical development phases being developed within Boston Global Development (BGD)/ Novo Nordisk. Representing Clinical Pharmacology on development and research project team(s), being responsible for the clinical pharmacology plan and dosing strategy and for the planning and oversight of Clinical Pharmacology trials. Providing clinical pharmacology expertise to Health Authority interactions, and regulatory submissions worldwide.
Reports to VP, Medical & Science.
Internal interactions: Medical and Science, Clinical Operations, Data Science, Phamacometrics, CMC, Project Vice President (PVP), Corporate Vice President (CVP).
External interactions: Global health authorities, IRBs/ECs and Vendors.
- Development and execution of clinical pharmacology strategy as a key member of global project teams and study teams
- Act as company expert on the Clinical Pharmacology section of Company dossier
- Provide clinical pharmacology expertise to the generation of the Product Development Plan (PDP) and other Project Strategic Documents
- Cross project clinical pharmacology coordination towards the PVP/CVP, Global Project Team (GPT) and core groups
- Provide clinical pharmacology expertise in a therapeutic area with focus on given project related trials to establish substantial evidence for safety and mechanisms of action in the clinical program
- Scientific communication and interactions with internal and external global stakeholders and key opinion leaders
- Provide clinical pharmacology support to Novo Nordisk Congresses, exhibitions, medical lounges and symposia for a given project
- Presentation of clinical pharmacology aspects of the global clinical development program at internal and external meetings such as meetings with health authorities, congresses, investigator meetings
- Prepare (or provide input) to secure high level clinical pharmacology publications
- Interactions with Health Authorities (including authoring clinical pharmacology summaries, meeting requests and briefing documents)
- Prepare and/or supervise clinical pharmacology summaries for interactions with health authorities
- Provide post-submission support to achieve regulatory approval and optimal labelling to allow successful launch of the drug
- Prepare high-level clinical pharmacology documents for submission of new drug applications worldwide
- Effective oversight of clinical pharmacology trials (including study design, interpretation and communication of results)
- Scientifically responsible for trial planning, protocol outline, protocol, conduct and reporting
- Reviewer of all clinical pharmacology Protocol Outlines and protocols within a given project
0-10% travel required. Approximately 5% overnight travel.
Preferred:Hands-on experience with PK analysis (noncompartmental, population PK)Experience with multiple drug modalities is a plus
- M.S. required with 7+ years of pharmaceutical/biotechnology industry experience.
- PharmD or PhD in Clinical Pharmacology or related field is preferred with a minimum of 5 years of clinical pharmacology experience.
- Expert knowledge of Clinical Pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
- Experience with health authority interactions
- Proven track record in planning and conducting clinical trials and working in cross-functional teams
- Experience integrating Modeling and Simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan
- Excellent communication and interpersonal skills
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.