Associate Director - Early Pipeline Medical Affairs

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Process

The Associate Director, Early Pipeline Medical Affairs, serves as an integral member of the Medical Affairs organization on trial readiness for early assets and by supporting pipeline business execution, analysis, and communication. The Associate Director, Early Pipeline Medical Affairs, is responsible for developing and communicating medical understanding in early asset spaces, as it pertains to trial readiness and execution. The Associate Director has overall responsibility for coordinating and executing projects designed to support entry into new therapeutic areas (TAs), which may include clinical trial strategy / program support and TA / stakeholder engagement planning. This role interfaces with key stakeholders across Clinical, Medical, & Regulatory (CMR), Global, and Future Business Strategy (FBS) to obtain relevant information and milestones and coordinate Medical Affairs input. The Associate Director also supports the Alignment Director in ensuring our scientific and medical strategies are executed within the Pipeline Field Medical Affairs (FMA) teams. The position supports the Alignment Director in the analysis of insights and identification of key themes shared across regions. This role has a critical impact on the Medical Affairs organization through insight sharing and coordinating US input that can help shape the global development program and adequately prepare the US Medical Affairs organization for timely engagement in market development and clinical development programs.

Relationships

Position reports to the Alignment Director, Pipeline Medical Affairs and is responsible for medical trial readiness for early assets and for developing and communicating medical understanding and insight in early assets as it pertains to the trials. The position is also responsible for working with the Alignment Director in supporting Pipeline FMA teams. Additional key internal relationships include Medical Affairs Management, Medical Directors, Medical Communications, CMR Program Development and Training, Clinical Trial Management, and Clinical Development as well as key roles within Global.

Essential Functions

• Lead the development and execution of therapeutic / scientific area development and engagement strategies for early assets
• Lead coordination of Medical Affairs recommendations for Phase 1 forward clinical programs through alignment with North American Clinical Development (NACD), Clinical Data Science & Evidence (CDSE), and Medical Affairs Leadership, as well as Global Study Recruitment and Retention teams
• Represent Pipeline Medical Affairs group with key internal stakeholders cross-functionally to provide key pipeline medical and scientific input to support business-critical projects
• Lead provision of NNI Medical Affairs input into Product Development Plan (PDP) updates and Evidence Generation Plans (EGPs) for early assets as required
• Lead collaboration with the members of the Program Development group and other relevant stakeholders to develop and implement departmental assessment strategies and tools to evaluate Medical Affairs scientific competencies and knowledge level for new therapeutic areas
• Support the Alignment Director in preparation and execution of the area business plans by performing data/insight analysis to identify area/region/territory specific opportunities
• Support clinical insight analysis, communication, and synthesis for Medical Affairs and key internal stakeholders
• Partners with operations in the generation and interpretation of Veeva data (execution and insight)
• Partners with operations in updating Veeva interface
• Responsible for measuring and reporting on impact of FMA including the support of NNI clinical trial programs
• Identify and pursue innovative ideas, solutions, methods or opportunities; foster innovation through appropriate risk-taking and experimentation
• Ensure critical projects are communicated, aligned, and coordinated across team members to optimize workflow according to business needs and business critical priorities

Physical Requirements

20-30% overnight travel required.

Qualifications

• A doctoral degree (PharmD, PhD or MD/DO) required
• Additional MBA or MHA preferred
• A minimum of 3 years of industry or related experience required.
• Previous experience in bringing early assets to market preferred
• Proven ability to build strong collaborative relationships required
• Experience with data analytics (via Excel) and the ability to interpret patterns and trends
• Solid understanding of US Healthcare Marketplace, including Managed Markets, Health Systems, etc.
• Cross-functional experience in multiple areas is strongly preferred
• Ability to manage multiple projects and engage stakeholders in a dynamic environment with tight timelines
• Demonstrated understanding of legal and regulatory environment of pharmaceutical industry
• Possess strategic thinking and problem-solving skills
• Possess superior communication skills, both oral, written and presentation, and ability to engender trust and respect of peers and superiors
• Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics
• Proficiency in PowerPoint, Excel and MS word software applications and overall advanced computer skills including Veeva or other CRM system required
• Proficiency in conducting literature searches
• Proven track record of strong teamwork, innovation, and project management

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.