Medical Director, Clinical Development

Company: Novo Nordisk
Location: Leominster
Posted on: January 27, 2023

Job Description:

About the DepartmentThe Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna's research pipeline of GalXC--- and GalXC-Plus--- RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team's rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?The PositionThe Medical Director will contribute to the development and execution of the clinical strategy and provide medical and scientific leadership and oversight for Novo Nordisk's clinical programs which are managed from the Boston Global Development location in Lexington, MA.This role works collaboratively with internal and external (KOLs, Clinical Investigators/site staff, patient advocacy groups) multi-disciplinary teams responsible for the design and implementation, monitoring, analysis, and reporting of clinical studies within the sRNAi platform to drive the execution of the Product Development Plan (PDP).RelationshipsThis position reports directly to the Vice President of Medical & Science and will be managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include (Regulatory, Clinical Operations, Data Sciences, Commercial, Research and Early Development and CMR), External relationships include Clinical Investigators/site staff, KOLs and, scientific consultants and patient advisory groups).Essential FunctionsProvide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP)Write medical aspects of core study and regulatory documents including, clinical protocols, investigator brochures, clinical study reports and regulatory submissionsProvide strategic input into clinical study design and development of clinical endpointsAttending study team meetings with internal teams, CROs and other vendors and providing medical oversight and clinical development guidanceSupport investigator meetingsServe on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to identify investigators/sites and risks to trial planning and executionMedical monitoring support to clinical investigators and internal/external team members (e.G., address medical and eligibility questions related to clinical protocols, answer product candidate related questions)Oversee safety for clinical studies (e.G., SAE reporting, ongoing review of events, integrated evaluation) in collaboration with the Drug Safety/Pharmacovigilance team and other external vendorsSupport other advisory boards with clinical data and other medical presentationsReview and interpret clinical trial data and assisting with preparation of periodic and final study reportsCollaborating with the medical affairs team and contribution to the development and review of scientific publicationsSupport preparation of regulatory documents (e.G., IND, NDA, MAA and other regulatory communications)Act as subject matter expert on clinical and medical strategic initiatives and provide internal training as neededDevelop and maintain strong, collaborative relationships with key internal and external stakeholders, including developing and moderating clinical advisory boards and drug safety monitoring boards (DSMBs)Physical Requirements0-10% overnight travel required.QualificationsM.D. required; additionally, a PhD would be ideal, not required.A minimum of 6 years relevant experience required; academic research and drug development experience required.Ideally board certification in nephrology, hepatology or pulmonologyStrong strategic mindset, understanding of market needs, resource allocation, etc.Strong strategic familiarity with the clinical program design and development of clinical endpoints, oversightPrior clinical research or related experience (e.G. monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience)Subspecialty training in relevant therapeutic area preferred.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.

Keywords: Novo Nordisk, Leominster , Medical Director, Clinical Development, Healthcare , Leominster, Massachusetts