Medical Director, Clinical Pharmacology

4+ years

$257,600 - $386,400/year

Hannover

10 July 10, 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, 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 Information:

Title: Medical Director, Clinical Pharmacology
Company: Novartis Biomedical Research (NBR)
Department: Translational Medicine (TM) Clinical Pharmacology
Location: East Hanover, NJ or Cambridge, MA (East Hanover, NJ preferred)
Job Type: Full Time
On-Site Requirement: This role is on-site and cannot be remote.

Company Overview:

Novartis Biomedical Research (NBR) is the innovation engine of Novartis, focusing on developing therapeutic breakthroughs. Translational Medicine (TM), part of NBR, includes about 900 associates globally, playing a crucial role in bringing innovative medicines to patients. TM Clinical Pharmacology specializes in the design, clinical execution, and reporting of First-in-Human (FiH) and Clinical Pharmacology studies across all TM therapeutic areas, utilizing a strategic outsourcing partnership with qualified CROs.

Position Summary:

The Medical Director, Clinical Pharmacology (MD CP) will provide medical and scientific leadership to support early and late-stage global programs across all BR therapeutic areas. The MD CP will be the primary contact for the Clinical Pharmacology Trial Team and CROs, ensuring medical supervision and execution of studies in the best interest of the program and participant safety.

Key Responsibilities:

Clinical Pharmacology Portfolio:
- Manage and lead multiple FiH and Clinical Pharmacology studies.
- Contribute Clinical Pharmacology expertise to develop Study Concept Sheets and Protocols.
- Review Informed Consent Forms, Statistical Analysis Plans, and study results.
- Provide medical and Clinical Pharmacology coverage for Site Initiation Visits, safety reviews, and medical coding.
- Develop Clinical Study Reports and contribute to study result publications.
Clinical Pharmacology Strategy and Initiatives:
- Contribute to strategic initiatives and process optimization in TM Clinical Pharmacology.
- Strengthen collaboration with internal stakeholders and external partners.

Impact of the Role:

The MD CP role significantly impacts the Novartis pipeline by supporting efficient clinical execution of FiH and Clinical Pharmacology studies, enabling result-based decision-making, and delivering key study results to support regulatory submissions. The MD CP will enhance the Medical Team's expertise and establish Novartis as a Center of Excellence for FiH and Clinical Pharmacology studies.

Diversity & Inclusion / EEO:

Novartis is an equal opportunity employer, committed to a diverse environment. We do not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other protected status. We strive to create an inclusive workplace that fosters innovation through collaboration.

Accessibility and Reasonable Accommodations: For reasonable accommodations due to a medical condition or disability, please contact:

Novartis: us.reasonableaccommodations@novartis.com or +1 (877) 395-2339
Sandoz: reasonable.accommodations@sandoz.com or +1-609-422-4098

Role Requirements:

Education:
- Medical Degree combined with a PhD/post-doctoral degree, specialized training (board certification), or clinical research experience in Clinical Pharmacology.
Experience:
- Significant clinical study experience in Clinical Pharmacology and FiH studies, preferably in the biopharmaceutical industry, CRO, or academic medical center.
- Track record of drug submissions/approvals and/or high-quality publications.
Skills:
- Full professional proficiency in English (written and spoken).

Compensation and Benefits:

Salary Range: $257,600 - $386,400/year (effective from 1/1/24 through 12/31/24, subject to adjustments).
Additional Compensation: May include a sign-on bonus, restricted stock units, and discretionary awards.
Benefits: Medical, financial, 401(k) eligibility, paid time off (vacation, sick time, parental leave), and more. Details will be provided upon offer of employment.

Why Novartis:

Our purpose is to reimagine medicine to improve and extend lives, driven by our associates' passion and dedication. Join us to be part of a mission to create breakthroughs that change patients’ lives.

Learn More:

Strategy and People & Culture: Novartis Strategy
Benefits and Rewards: Novartis Life Handbook
Join Our Network: Novartis Talent Network

Contact for Reasonable Accommodations:

Novartis: tas.nacomms@novartis.com or +1 (877) 395-2339

Ready to create a brighter future together? Join us at Novartis!

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