Senior Director - Clinical Pharmacology

Lexington, MA, United States

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

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.