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Associate Clinical Development Director

7+ years
$152,600 and $283,400/year
10 April 18, 2025
Job Description
Job Type: Full Time Education: PharmD/MD/PhD 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

 


Associate Clinical Development Director

Job ID: REQ-10047086
Date: Apr 11, 2025
Location: USA
State: New Jersey
Site: East Hanover
Division: Development
Business Unit: Innovative Medicines
Company / Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No

Summary:
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of assigned clinical program(s) from an end-to-end clinical development perspective. As a CDD in the Renal Therapeutic Area, you will oversee clinical development for assigned programs, drive execution of the clinical development plan, and enable an empowered organization that can navigate a matrix environment and adapt quickly to business needs.

Major Accountabilities:

  • Provide strategic input for all clinical deliverables in the assigned project or program section, including clinical sections of protocols, sub-studies, clinical data review, program-specific standards, regulatory documents, and publications.

  • Lead development of clinical sections for trial and program-level regulatory documents.

  • Drive execution of clinical programs in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable.

  • Oversee and conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts, under the appropriate oversight of the Medical Lead.

  • Support (Sr.) GPCH in ensuring overall safety of the molecule, serving as a core member of the Safety Management Team and supporting safety reporting in collaboration with Patient Safety.

  • Act as a clinical expert, supporting (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.

  • Contribute to the scientific training of Novartis stakeholders in the disease area and molecule; may serve as a speaker for franchise medical/scientific training sessions.

Minimum Requirements:

  • Advanced degree in life sciences/healthcare or a clinically relevant field required; PharmD or PhD strongly preferred.

  • Fluent in oral and written English.

  • Minimum 7 years of experience in clinical research or drug development.

  • Working knowledge of the assigned disease area with the ability to interpret, discuss, and present clinical efficacy and safety data.

  • Demonstrated ability to establish effective working relationships with key investigators.

  • Strong understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.

  • Excellent communication skills with the ability to work effectively in a cross-functional and global organization.

Compensation and Benefits:
The pay range for this position at the commencement of employment is expected to be between $152,600 and $283,400/year. Salary ranges are effective from 01/01/25 through 12/31/25 but may adjust based on market conditions. Final compensation will depend on geographic location, experience level, knowledge, skills, and abilities. The total compensation package may also include sign-on bonuses, restricted stock units, discretionary awards, and a comprehensive benefits package (including 401(k) eligibility, vacation, sick time, and parental leave). Specific participation details will be provided upon an offer of employment. Employment will be “at-will,” and the company reserves the right to modify compensation programs based on individual or business factors.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate individuals. At Novartis, we foster a collaborative, supportive, and inspiring environment focused on achieving breakthroughs that change patients’ lives. Learn more:
https://www.novartis.com/about/strategy/people-and-culture

Join Our Network:
If this role isn't the right fit, join our talent network to stay informed about future opportunities:
https://talentnetwork.novartis.com/network

Benefits and Rewards:
Learn more about our comprehensive benefits to help you thrive personally and professionally:
https://www.novartis.com/careers/benefits-rewards

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations:
We are committed to providing reasonable accommodation to individuals with disabilities. To request an accommodation during the application or employment process, email
us.reasonableaccommodations@novartis.com or call +1 (877) 395-2339, referencing the job requisition number.