Manager - Clinical Contracts - Scientific Alliance Management (REMOTE)

Facility:  Clinical Development and Medical
Location: 

Plainsboro, NJ, US

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 Position

Assist in managing internal and external strategic collaborations to optimize alliance performance by building relationships, developing and maintaining strong communication channels. Supports investigator and strategic partnership negotiations in accordance with all relevant regulations and policies; (Good Clinical Practice (GCP), ICH guidelines, federal regulations (Sunshine/Open Payments Act), and within defined budgeting guidance). Ensures clinical trial readiness through the procuring and managing of ancillary supplies and printed materials. Assist Associate Director in development of team process and strategies, as well as team management, internal and external escalations. Coach and develop a team of Contract Specialists, including internal and external contracted team members. Develop contracting strategies and process improvements collaborating with Associate Managers and ensure roll out and execution by Contract Specialists.

 

Relationships

Reports to the Associate Director Scientific Alliance Management. Accountable for managing relationships with external partners relevant to the planning and execution of CMR initiatives; actively participating in multiple internal cross-functional teams to ensure the effective delivery of all functional and departmental milestones. Effectively manages a team to the CMR strategy through effective contractual negotiations NNI Sponsored and Investigator Sponsored Research. External relationships are with clinical investigators, suppliers/vendors Health Systems, Contract Research Organizations & Site Management Organizations as needed to support business objectives for the department and/or function. Develop clinical contract strategy and process improvements in alignment with industry trends and organization need, collaborating with Scientific Alliance Management (SAM) Associate Managers – Clinical Contracts.

 

Essential Functions

  • Leads NACO strategy for contract and budget negotiations through understanding and tactics to develop, execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality. Leads strong and effective communication to global and local stakeholders to ensure consistency across NACO
  • Manage a team of Contract Specialists, ensuring delivery to NACO trial strategies and timelines, as well as development of people
  • Reviews and interprets clinical trial protocols for the development of investigator budget and site contracts for North America (US and Canada) Clinical Operations (NACO)
  • Influences, leads, and effectively interfaces within a matrixed environment and with varying professional levels
  • Demonstrates a commitment to quality, attention to detail and provides the highest quality services to internal and external stakeholders
  • Maintains and builds knowledge of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
  • Leads & delivers upon improvement/innovation projects for the department and/or as part of a global team and as aligned to a business case, goals &/or future aspirations
  • Responsible for alignment with portfolio guidance to staff with respect to investigator site contracting, FMV & Open Payments Act adherence
  • Manages and communicates budget and contract status of upcoming and ongoing clinical trials, including identification of financial and timeline risks.  Identifies opportunities and potential mitigations and works with cross-functional teams to develop new forecasts as required
  • Understands governance of relevant contracts and provides support to Associate Director with external partners to coordinate, communicate and document governance matters
  • Serves as a champion for the relationship with external parties, anticipating partnership-driven next-steps ahead of leadership meetings or other related communication.  Engages and seeks input of others, continually connecting moving parts, and with ongoing communication that encourages an outcome driven commitment to the alliance
  • Thinks strategically and initiates strong and persuasive contractual arguments to support business policies and objectives

 

Physical Requirements

0-10% overnight travel required. The incumbent can work remotely from anywhere in the United States. 

 

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

  • Bachelors degree required; Advanced degree preferred
  • A minimum of 8 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 3 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)
  • Experience in budget and contract negotiations with clear understanding/impact of contract and financial schedules, (i.e. cost benefit analysis, ROI, KPI, financial milestones and related payment schedules)
  • Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the application of those principles to trial design, planning & conduct of clinical trials
  • Advanced capability in MS Excel, MS PowerPoint and MS Word required
  • Proven leadership ability to engage teams across functions of varying levels and experience
  • Strong negotiation skills with the ability to understand, identify, and explain contractual risk
  • Strong analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
  • Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings
  • Demonstrated ability to collaborate with local and global stakeholders to design and execute analyses to support decision-making and planning
  • Excellent skills in designing and implementing innovation/improvement initiatives, including the required change management

 

The base compensation range for this position is $130 to $150K. Base compensation is determined based on a number of factors. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and other Company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its uncapped sick time policy, flex-able vacation policy, and parental leave policy.

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.