Novo Nordisk
Senior Director - Clinical Pharmacology
Novo Nordisk, Lexington, Massachusetts, United States, 02173
Senior Director - Clinical Pharmacology
Facility:
Clinical Development
Location:
Lexington, MA, US
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. 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 Senior Director 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 programme 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 VP of Medical & Science 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 and Rare Diseases and Advanced Therapies.
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
Dosage and administration strategy, including dose setting and dosing regimen for project(s)
Develop dosage and administration strategy for project(s) and align with GPT(s) and MST(s) (if applicable) and line of business
Maintain overview of
PK/PD properties of drug and commercial aspirations for dosage and administration
Activities that impact dosage and dose setting including CMC, Device, Non-clin and clinical activities
Available and future studies that can support dose setting
Scientific and pharmacology aspects of trials in the clinical development programme
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
Support scientific aspects of clinical trial application and trial conduct
Provide clinical pharmacology input to Health Authority and Ethics Committee
Be contact to Investigator on scientific aspects of the trial
Facilitate trial safety groups in First human dose (SAD/MAD) studies
Take responsibility for assessment, evaluation, and interpretation of scientific data until reporting of trial is complete
Ensure scientific quality in data interpretation
Clinical Study Reports and publications
Internal and external presentation and communication of data
Internal presentation for decision making
Knowledge-sharing as expert in clinical pharmacology, PK/PD, dosage and administration
Development of own competencies in clinical pharmacology, PK/PD and dosing aspects in perspective of the assigned project(s)
Preparation and presentation of publications
Interpretation of external and competitor data
Due diligences
Support and maintenance of an external network, e.g. advisory boards, including investigators, key opinion leaders and key research scientists
Active contribution of knowledge sharing in project, in clinical pharmacology team and with stakeholders outside the project/teams
Managing a team of Clinical Pharmacologists
Physical Requirements
Ability to travel occasionally – both internationally (our headquarters are located in Denmark) and domestically in the U.S. Ability to lift 0-50 lbs.
Development of People
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
MSc or PhD in pharmacology or other relevant field with 12+ years of relevant experience
Expert knowledge in clinical pharmacology
Solid experience with strategic planning of clinical development within the pharmaceutical industry
Solid expertise from managing clinical pharmacology projects
Expert knowledge of trial designs within clinical pharmacology and knowledge of clinical trial methodology
Solid drug development expertise
Relevant therapeutic area expertise/knowledge
Previous experience as a people manager
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Facility:
Clinical Development
Location:
Lexington, MA, US
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. 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 Senior Director 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 programme 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 VP of Medical & Science 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 and Rare Diseases and Advanced Therapies.
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
Dosage and administration strategy, including dose setting and dosing regimen for project(s)
Develop dosage and administration strategy for project(s) and align with GPT(s) and MST(s) (if applicable) and line of business
Maintain overview of
PK/PD properties of drug and commercial aspirations for dosage and administration
Activities that impact dosage and dose setting including CMC, Device, Non-clin and clinical activities
Available and future studies that can support dose setting
Scientific and pharmacology aspects of trials in the clinical development programme
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
Support scientific aspects of clinical trial application and trial conduct
Provide clinical pharmacology input to Health Authority and Ethics Committee
Be contact to Investigator on scientific aspects of the trial
Facilitate trial safety groups in First human dose (SAD/MAD) studies
Take responsibility for assessment, evaluation, and interpretation of scientific data until reporting of trial is complete
Ensure scientific quality in data interpretation
Clinical Study Reports and publications
Internal and external presentation and communication of data
Internal presentation for decision making
Knowledge-sharing as expert in clinical pharmacology, PK/PD, dosage and administration
Development of own competencies in clinical pharmacology, PK/PD and dosing aspects in perspective of the assigned project(s)
Preparation and presentation of publications
Interpretation of external and competitor data
Due diligences
Support and maintenance of an external network, e.g. advisory boards, including investigators, key opinion leaders and key research scientists
Active contribution of knowledge sharing in project, in clinical pharmacology team and with stakeholders outside the project/teams
Managing a team of Clinical Pharmacologists
Physical Requirements
Ability to travel occasionally – both internationally (our headquarters are located in Denmark) and domestically in the U.S. Ability to lift 0-50 lbs.
Development of People
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
MSc or PhD in pharmacology or other relevant field with 12+ years of relevant experience
Expert knowledge in clinical pharmacology
Solid experience with strategic planning of clinical development within the pharmaceutical industry
Solid expertise from managing clinical pharmacology projects
Expert knowledge of trial designs within clinical pharmacology and knowledge of clinical trial methodology
Solid drug development expertise
Relevant therapeutic area expertise/knowledge
Previous experience as a people manager
#J-18808-Ljbffr