Clinical Development Medical Director, Nuclear - East Hanover, United States - Novartis

Novartis
Novartis
Verified Company
East Hanover, United States

1 month ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

About the Role:


Hybrid:
East Hanover, New Jersey

LI-Hybrid
Novartis Oncology has a renowned history in oncology and developing transformative radioligand therapies for patients.

As our Clinical Development Medical Director, Nuclear Medicine, you will be the clinical leader of defined program-level activities such as submission activities, preparing briefing books or transformative trials, under the leadership of the Global Program Clinical Head.

You may lead a section of a clinical program, an indication, new formulation, or specific development phase.

Your Key Responsibilities:

  • Provide clinical leadership and medical & strategic input for all clinical results in the assigned project or a section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Clinical Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, radioligand therapy related education and publications
  • Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  • Drive execution of the section of the clinical program in partnership with line functions, assigned Clinical Operations Program Head, and regional/country medical associates if applicable
  • Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
  • May be the Program Manager of other associates. Support the GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs) and other safety related documents) in collaboration with Patient Safety
  • Work with the Clinical Development Head (CDH) providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
  • Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
  • Work with Biomedical Research (BR)/Translational Medical Sciences to drive the Research-DevelopmentCommercial continuum and with Business Development & Licensing


The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity).

Please note that this role would not provide relocation as a result.

If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense.

The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.


Diversity & Inclusion / EEO:


  • We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._

Role Requirements:


Required:

  • MD or equivalent medical degree required. Extensive knowledge and clinical training in nuclear medicine. Nuclear Medicine Physician (EU or US Board certified)
  • 5+ years direct involvement in clinical research or drug development in an academic or industry environment or equivalent, spanning clinical activities preferably in Phases I through IV. Having contributed to and accomplished in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry or equivalent
  • Clinical experience in oncology PET or equivalent

Desired:

  • Experience with radioligand therapy
  • Detailed knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
  • People management experience preferred; this may include management in a matrix environment
  • Excellent negotiation, conflict resolution and communication skills (written and oral).

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining

Commitment to Diversity
More jobs from Novartis
See all jobs of Novartis