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Clinical Development Medical Director - Rheumatology

3-5 years
Not Disclosed
10 Oct. 9, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Summary
As a Clinical Development Medical Director in Rheumatology, you will lead the scientific and clinical strategy for assigned clinical trials, ensuring high-quality data monitoring and reporting. You will be the clinical leader for specific program-level activities (e.g., submissions, clinical study reports) and manage complex trials under the guidance of the Global Program Clinical Head (GPCH).

About the Role
Major Accountabilities:

  • Provide clinical leadership and strategic medical input for project/program deliverables, including protocols, data reviews, and regulatory documents.
  • Drive execution in collaboration with global functions, Global Trial Directors, and regional medical associates.
  • Oversee medical and scientific review of trial data, potentially serving as study medical monitor.
  • Support GPCH in ensuring overall safety of the molecule and participate in safety management teams.
  • Contribute to the development of clinical standards and provide medical input for clinical development plans.
  • Engage with external partners (regulatory authorities, key opinion leaders) and internal stakeholders (clinical trial teams, Medical Affairs).
  • Collaborate with Novartis Biomedical Research to transition early development projects.
  • Mentor and support the career development of Program Reports and clinical colleagues through performance management and training.
  • Conduct medical/scientific training for relevant stakeholders and may serve as a speaker for global teams.

Minimum Requirements:

  • MD (or equivalent) required; training in Immunology/Rheumatology/Dermatology preferred.
  • 4+ years of clinical practice experience, including residency.
  • 5+ years in clinical research or drug development in the pharmaceutical/biotechnology industry, across phases I to IV.
  • Proven experience in all aspects of clinical trials in a global/matrix environment.
  • Strong knowledge of the therapeutic area and the ability to establish scientific partnerships.
  • Thorough understanding of Good Clinical Practice, clinical trial design, and regulatory processes.
  • People management experience preferred, especially in a global context.

Why Novartis:
At Novartis, our mission is to improve and extend people's lives through innovative science and a collaborative culture. Join us in making a meaningful impact. Learn more about our vision here.

Join Our Novartis Network:
If this role isn’t right for you, consider joining our talent community to stay connected and learn about future opportunities: Novartis Network.

Benefits and Rewards:
Discover how we support your personal and professional growth in the Novartis Life Handbook: Benefits & Rewards.

EEO Statement:
Novartis is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We celebrate differences and do not discriminate in any employment practices.

Accessibility & Reasonable Accommodations:
We are dedicated to providing reasonable accommodations for individuals with disabilities. If you need assistance, please contact us at us.reasonableaccommodations@novartis.com.

Division: Development
Business Unit: Innovative Medicines
Location: USA (East Hanover)
Alternative Locations: Basel, Switzerland; Dublin, Ireland; Hyderabad, India
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No