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Clinical Development Medical Director

3+ years
$257,600.00 - $386,400.00
10 Aug. 13, 2024
Job Description
Job Type: Full Time 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

Position Title: Clinical Development Medical Director

Location: East Hanover, New Jersey (On-Site Only)
Schedule: Full-Time
Date Posted: August 5, 2024

Company: Novartis Group Companies

About the Role:

Novartis is committed to transforming the lives of patients with solid tumors, blood cancers, and serious blood disorders. We are dedicated to developing innovative treatments that aim to alleviate pain, symptoms, and disease for those affected. As a Clinical Development Medical Director (CDMD) in our Research & Development team, you will lead the strategic planning and management of clinical programs, ensuring the execution and success of clinical trials from start to finish.

Key Responsibilities:

  • Clinical Leadership: Provide strategic medical input and leadership for all clinical deliverables within assigned projects or clinical program sections.
  • Regulatory Documents: Develop and oversee the clinical sections of trial and program-level regulatory documents.
  • Program Execution: Drive the execution of clinical programs and trials in partnership with global line functions, Global Trial Directors, and regional medical associates.
  • Safety Management: Support the Global Program Clinical Head in monitoring and ensuring the safety of the molecule, including participation in the Safety Management Team.
  • Development Planning: Contribute medical expertise to the Clinical Development Plan, Integrated Development Plan, and Clinical Trial Protocol reviews. Assist in developing disease-specific clinical standards.
  • External Partnerships: Support interactions with external and internal partners and decision boards.
  • Preclinical Transition: Collaborate with the Novartis Institute of Biomedical Research and Translational Medical Sciences to transition pre-proof-of-concept projects to Development and Business Development and Licensing (BD&L) teams.

Qualifications:

  • Education: MD or equivalent medical degree is required.
  • Experience: Minimum of 3 years in clinical research or drug development, with a strong background in Hematology/Oncology.
  • Knowledge: Extensive understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
  • Skills: Proven ability to establish scientific partnerships, interpret and present clinical data, and manage global teams effectively.
  • Desirable: Clinical practice experience (4+ years including residency) and prior experience managing teams in a matrix environment.

Benefits:

  • Competitive salary ranging from $257,600 to $386,400 per year.
  • Annual bonus and pension scheme.
  • Share scheme and health insurance.
  • 25 days of annual leave.
  • Flexible working arrangements and subsidized dining facilities.
  • Employee recognition scheme and learning and development opportunities.

Why Novartis?

At Novartis, we are dedicated to enhancing and extending lives through innovative treatments. We foster a diverse, equitable, and inclusive environment where new insights and groundbreaking solutions thrive at the intersection of medical science and digital innovation. Join us to be part of a culture that values integrity, curiosity, and collaboration to tackle the world's toughest medical challenges.

Application Instructions:

To apply, please visit our career page. For any accommodations or disability-related inquiries, contact us at tas.nacomms@novartis.com or +1 (877) 395-2339.

EEO Statement:

Novartis Group of Companies is an Equal Opportunity Employer. We are committed to creating a diverse environment and do not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital status, veteran status, disability, or any other legally protected status.

Join our Novartis Network: If this role isn't a perfect fit but you're interested in staying connected, join the Novartis Network here: Novartis Talent Network.