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Associate Director/Director Pk Sciences - Oncology

5+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: Ph.D. / Pharm.D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: PK Sciences Project Team Representative
Company: Novartis Institutes for BioMedical Research, Inc.
Location: Cambridge, MA (Hybrid)
Division: Biomedical Research
Business Unit: Pharma Research
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No


Role Purpose

The PK Sciences Project Team Representative is a critical role focused on developing and implementing DMPK (Drug Metabolism and Pharmacokinetics) and clinical pharmacology strategies to support the development of transformative medicines. This position involves working across discovery and clinical phases, including small molecules, biologics, antibody-drug conjugates, radioligand therapies, and/or cell therapies. The role offers an exciting opportunity for hands-on work in the preclinical and clinical space, bridging early-stage discoveries to clinical applications.

Key Responsibilities

  • Project Team Representation:

    • Represent PK Sciences within project teams, working with internal stakeholders and regulatory agencies.
  • Strategy Development & Execution:

    • Develop PK strategies for lead optimization, guiding the execution of nonclinical studies to identify compounds with favorable DMPK properties.
    • Collaborate with teams to understand PK/PD (pharmacokinetics/pharmacodynamics) relationships and develop dosing strategies and predictions.
  • Clinical Pharmacology & Study Design:

    • Develop and execute clinical pharmacology strategies, including contributions to study designs and analysis of PK/PD data.
    • Provide expertise in writing pharmacokinetic, clinical pharmacology, and biopharmaceutics sections for IND/IMPDs, NDA/BLAs, and responses to Health Authority inquiries.
  • Collaborative Role in Translational Medicine:

    • Work within Translational Medicine to bridge drug discovery and clinical application, particularly in radioligand therapies and precision imaging agents for targeted tumor treatment.

Minimum Requirements

  • Education:

    • Ph.D. or Pharm.D. with a background in clinical pharmacology, drug metabolism, pharmacokinetics, or related fields.
  • Experience:

    • Minimum of 5 years of experience in drug discovery or development in academia, CRO, biotech, or pharmaceutical industries.
    • At least 8 years of experience for Director level, including 5 years in a lead role overseeing ADME/DMPK project strategy.
    • Extensive knowledge of pharmacokinetics, drug metabolism, and PK/PD evaluation.
    • Strong cross-functional collaboration and project-team experience, ideally in global teams.
  • Additional Expertise (Preferred):

    • Hands-on project experience with drug conjugates or radiopharmaceuticals is a plus.

Why Novartis?

Novartis is driven by its mission to improve and extend people's lives through innovation. By fostering a collaborative and inclusive environment, Novartis empowers employees to contribute to cutting-edge research and breakthroughs that transform patient outcomes.

Benefits & Rewards

Novartis offers a comprehensive benefits package, including competitive compensation, health and wellness programs, paid time off, 401(k), and more. For full details, visit: Novartis Benefits & Rewards.

Commitment to Diversity & Inclusion

Novartis is committed to building an inclusive and diverse workforce that reflects the communities we serve, promoting equal opportunities and celebrating diverse perspectives.

Join the Novartis Network

If this role is not a perfect fit, stay connected by joining the Novartis talent community to receive updates on future career opportunities: Novartis Talent Network.

EEO & Accessibility

Novartis is an Equal Opportunity Employer and provides accommodations for individuals with disabilities. If you require assistance during the application process, please reach out to: us.reasonableaccommodations@novartis.com.