Clinical Development Medical Director - Rheumatology

3-5 years

Not Disclosed

Remote, USA

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

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Clinical Development Medical Director - Rheumatology

Job Description

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