Novartis-posted 7 months ago
$261,100 - $484,900/Yr
Full-time • Senior
East Hanover, NJ
Chemical Manufacturing

The position involves designing and overseeing clinical research programs, building relationships with key opinion leaders, and applying their input to enhance study design and protocols. The role serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies, establishing criteria essential for determining safety, efficacy, and medical utilities. Responsibilities include interpreting results of Phase I-III investigations in preparation for new-drug or medical device applications, and may involve serving as a safety expert for individual clinical projects. The position also entails serving as the Clinical Development Representative on Biomedical Research (BR) clinical/project teams to drive the transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP). The role supports Business Development & Licensing (BD&L) activities and leads the Global Clinical Team (GCT), representing Clinical Development on the Global Program Team (GPT). Post-Transition Development Point, the position leads the development and execution of the clinical strategy, developing an endorsed Integrated Development Plan (IDP) aligned with the Target Product Profile (TPP) for successful global regulatory approval and market access for one or multiple treatment indications and/or multiple programs. The role also involves leading the creation of clinical components of key documents with high quality and consistency with IDP and TPP, supporting registration, market access, commercialization, and maintenance of product licenses, and ensuring continuous evaluation of drug safety profiles.

  • Designs and provides oversight of clinical research programs.
  • Builds relationships with key opinion leaders and applies their input to enhance study design and protocols.
  • Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies.
  • Establishes criteria essential for determining safety, efficacy, and medical utilities.
  • Interprets results of Phase I-III investigations in preparation for new-drug or medical device applications.
  • May serve as safety expert for individual clinical projects.
  • Serves as the Clinical Development Representative on Biomedical Research (BR) clinical/project teams.
  • Supports Business Development & Licensing (BD&L) activities.
  • Leads the Global Clinical Team (GCT) and represents Clinical Development on the Global Program Team (GPT).
  • Leads the development and execution of the clinical strategy post-Transition Development Point.
  • Develops an endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP).
  • Leads the creation of clinical components of key documents such as Clinical Trial Protocols, Investigator's Brochures, and Clinical Study Reports.
  • Supports registration, market access, commercialization, and maintenance of product licenses.
  • Ensures continuous evaluation of drug safety profile in collaboration with Patient Safety.
  • Leads interactions with external and internal stakeholders.
  • MD or equivalent (preferred), or PharmD, PhD.
  • 6 years professional experience with MD or equivalent or 10 years with PharmD or PhD in clinical research or drug development.
  • Expertise in cardiovascular disease.
  • Advanced knowledge of assigned therapeutic area.
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.
  • Experience with submissions and health authorities.
  • Demonstrated ability to establish strong scientific partnerships with key stakeholders.
  • Demonstrated leadership and management skills with a track record of delivering high quality projects/submissions/trials.
  • 401(k) eligibility
  • various paid time off benefits, such as vacation, sick time, and parental leave
  • sign-on bonus
  • restricted stock units
  • discretionary awards
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