Director - Safety Surveillance

About the Department

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, 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. Our R&D 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.

The Position

This leadership role leads the safety surveillance sub-function within the U. S. East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety Scientists and Safety Scientists.

Contributes and provides oversight in the development of safety strategy and safety deliverables for assigned programs within the U. S. East Coast Development Hub portfolio in close collaboration with key stakeholders from Global Safety Surveillance and other cross functional teams.

Oversees daily operations of the function by directing staff and adhering to company-wide policies, procedures and programs. Manages organizational design, structure, development, training and planning issues within sub-function. Solid NN value chain understanding and execution. Proven track record of creating business results with impact on VP/CVP level.

Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders.

Relationships

This position will report to Senior Director Safety Surveillance, U. S. East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and other affiliates.

External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/Associate within Safety Surveillance.

Essential Functions

Innovation and change

Identifies needs and opportunities for overall strategic changes in the culture and organization or in the way by which the business is positioned

Identifies problems and significantly changes or improves existing methods and techniques drawing from personal experiences and feedback

Decisions are guided by strategic and tactical priorities and require complex analysis of situations and data

Establishes new or improved methods within field of expertise across EVP area

Geographic responsibility

Ensures global scalability of solutions and understands the importance of involving various global stakeholders

Considers the impact of decisions and initiatives on other areas of the organization

Strong international visibility and independent interaction with the business globally

Establishment of the product safety profile

Develop and update the minimum mandatory safety text (MMST) for use in the Informed Consent

Own the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products

Maintain the labelling for marketed products and is member of the Product Labelling Committee (PLC) Review Group

Review/approve deliverables of the safety surveillance team

Safety surveillance of Novo Nordisk products during pre-approval and post-approval phases

Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), takes initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and documents the results of the safety surveillance for the period

Conduct periodic literature surveillance for marketed products and for development products (if applicable)

Provide input to preparation of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by Has

Respond to requests from HAs and internally from NN affiliates and HQ functions

Conduct product training within therapeutic area of responsibility


Chairmanship/membership of the NN cross-functional safety committees

Participate as a member of the first safety committee chaired by non-clinical, where Safety Surveillance will resume chairmanship going forward

Establish, operate and chairs the safety committee throughout lifecycle of the actual product

Responsible for all areas related to patient safety in clinical trials

Act as member of the trial safety group for dose escalation decisions (phase I trials)

Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), integrated safety summaries, abstracts and planned publications

Provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required

Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs)

Establish and ensure deliverables to/from Data Monitoring Committees (DMCs)

Review and approve deliverables of the safety surveillance team

Is safety representative in Trial Squad

Plan, execute and drive all activities related to safety and ensure coordination with other project deliverables

Is safety representative in cross functional project teams as needed e. g. Global Project Team (GPT)

Plan, execute and drive all activities related to safety and ensures coordination with other project deliverables

Is responsible for Safety Input to all activities for Risk Based Monitoring across the development project

Physical Requirements

Approximately 10% overnight travel required.

Development of People

Supervisory

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

MD or PhD or equivalent degree with 10+ years of relevant experience or a life scie.