(Senior) Clinical Development Director

Novartis; East Hanover (NJ); On-site; USD 204,000 - 380,000; Full time

Job summary

An established industry player is seeking a Clinical Development Director to lead strategic planning and management of clinical programs in the Cardio Renal & Metabolic Development Unit. In this pivotal role, you will provide clinical leadership, oversee trial execution, and engage with stakeholders as a clinical expert. This position offers a competitive salary and the opportunity to work in a collaborative environment focused on advancing innovative healthcare solutions. If you possess extensive experience in clinical research and a passion for drug development, this role is tailor-made for you.

Qualifications

• 10+ years in clinical research and global drug development.
• Strong scientific writing skills and regulatory submission experience.

Responsibilities

• Lead clinical development and strategic input for clinical programs.
• Oversee scientific review of clinical trial data.

Skills

Budget Management

Clinical Research

Clinical Trials

Coaching

Cross-Functional Teams

Lifesciences

People Management

Risk Management

Risk Monitoring

Education

Advanced degree in life sciences or healthcare (PharmD, PhD preferred)

Job description

Job Description Summary

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

Job Description

Major accountabilities:

1. Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Deliverables include clinical sections of protocols, data review, program standards, regulatory documents, and publications.
2. Leading development of clinical sections of trial and program-level regulatory documents.
3. Driving execution of the clinical program section in collaboration with global line functions, Global Trial Directors, and regional/country medical associates.
4. Overseeing scientific review of clinical trial data with Clinical Scientific Experts under Medical Lead oversight.
5. Supporting safety of the molecule for the assigned section, potentially serving on the Safety Management Team and collaborating on safety reporting.
6. Engaging with stakeholders as a clinical expert, supporting interactions with external and internal stakeholders and decision boards.
7. Contributing to scientific training of relevant stakeholders and potentially serving as a speaker or Program Manager.

Work Experience:

• Advanced degree in life sciences or healthcare (PharmD, PhD preferred).
• ≥ 10 years in clinical research and global drug development, with ≥ 5 years in clinical trial execution in a pharmaceutical industry setting, including late-phase development experience.
• Strong scientific writing skills.
• Experience with regulatory submissions is preferred.
• Ability to analyze and interpret scientific data and literature.
• Knowledge of the assigned therapeutic area is preferred.
• Proven ability to establish scientific partnerships.
• ≥ 3 years of people management experience, including in a matrix environment.

Final job title will be Senior Clinical Development Director or Clinical Development Director, depending on expertise.

Compensation and Benefits: The salary range at start is expected to be between $204,400 and $379,600/year, subject to adjustments based on market and individual factors. The package may include bonuses, stock units, and other benefits, with details provided upon offer. The position is at-will, with the company reserving the right to modify compensation.

EEO Statement: We are an Equal Opportunity Employer, committed to diversity and inclusion in employment practices.

Accessibility and Accommodations: We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone], including the job requisition number.

Salary Range: $204,400 - $379,600

Skills Desired: Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring