Novartis

Associate/Director - Translational Medicine Expert, Discovery

Novartis

full-time

Posted on:

Location Type: Hybrid

Location: London • Massachusetts • 🇺🇸 United States

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Job Level

Lead

About the role

  • Provide medical and scientific expertise and leadership to drive success of early global programs and implement strategies to transition to late-stage development
  • Develop and implement clinical pharmacology and profiling packages for late-stage programs that meet regulatory requirements and support differentiated drug labeling
  • Support translational research for new indications, endpoints and biomarkers using in vitro, in vivo, or in silico methods
  • Provide scientific expert assessments and due diligence support for in-licensing opportunities
  • Lead global cross-functional project teams through early clinical phases (Phase I/II) and drive implementation of development strategy
  • Act as key leader for Ph2-3 and post-approval profiling strategy and represent TMDP on Global Project Team
  • Provide support for dose selection, study design and other clinical pharmacology matters across development cycle
  • Oversee conduct and interpretation of studies prioritized to support pivotal trials and drive analysis and presentation of results to decision boards
  • Write Translational Medicine portions of regulatory submission documents
  • Participate in Business Development & Licensing teams as the TM representative and subject matter expert
  • Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
  • Provide medical and scientific leadership to line functions, represent TM aspects to Health Authorities, payers and patient advocacy groups
  • Oversee publication strategy for TM studies, lead writing of scientific publications, and present study results externally
  • Lead study-specific clinical trial teams and collaborate closely with TM and non-TM line functions to ensure operational excellence, timelines, costs, and subject burden are balanced with scientific standards and innovation

Requirements

  • Doctoral degree, MD required with clinical subspecialty training in dermatological diseases
  • Additional PhD/post-doctoral equivalent research and relevant Board certification preferred
  • Associate Director Level: 1-2 years of experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
  • Director Level: 5+ years of experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
  • Recognized medical expertise evidenced by publication of significant contributions
  • Excellent written and oral communication/presentation skills
  • Able to work independently, demonstrate innovation, and lead multidisciplinary teams in a matrix organization
  • Willingness to collaborate and interact with other TMEs
  • Position located at Cambridge, MA, London, UK or Basel, Switzerland site and will not be remote
  • Approximately 7% travel (domestic and/or international)
  • Skills desired: Active Directory; Artificial Intelligence (AI); Biostatistics; Classification Systems; Clinical Pharmacology; Drug Discovery; Modeling And Simulation; Medical Research; Patient Care; Personalized Medicine; Translational Medicine; Regulatory and clinical trial experience
Benefits
  • You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
  • Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical pharmacologybiostatisticsdrug discoverymodeling and simulationtranslational medicineregulatory experienceclinical trial experiencein vitro methodsin vivo methodsin silico methods
Soft skills
leadershipcommunication skillsinnovationcollaborationindependencepresentation skillsmultidisciplinary teamworkorganizational skillsscientific expertiseproblem-solving
Certifications
MDPhDBoard certification