Associate Clinical Development Director

Novartis Farmacéutica; East Hanover (NJ); On-site; USD 152,000 - 284,000; Full time

Job summary

An established industry player is seeking a Clinical Development Director to lead strategic planning and management of clinical programs. In this pivotal role, you will oversee clinical development, ensuring effective execution of clinical plans while collaborating with global teams. Your expertise in clinical research and drug development will be essential in guiding the organization through complex challenges. This position offers a unique opportunity to make a significant impact on patient outcomes while working in a dynamic and supportive environment. Join a passionate team dedicated to transforming lives through innovative science and collaboration.

Benefits

401(k) eligibility

Paid time off benefits

Sign-on bonus

Restricted stock units

Qualifications

• Minimum 7 years experience in clinical research or drug development.
• Strong communication skills with the ability to work in a cross-functional organization.

Responsibilities

• Lead strategic planning and management of assigned clinical programs.
• Drive execution of clinical development plans in partnership with global teams.

Skills

Clinical research

Drug development

Communication skills

GCP knowledge

Statistics

Education

Advanced degree in life sciences

PharmD or PhD

Job description

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 have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

About the Role

Major Accountabilities

1. Providing strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
2. Leading development of clinical sections of trial and program level regulatory documents.
3. Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable.
4. Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead.
5. Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety.
6. As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
7. Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training.

Minimum Requirements

1. Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred.
2. Fluent oral and written English.
3. Minimum 7 years experience in clinical research or drug development.
4. Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level.
5. Demonstrated ability to establish effective working relationship with key investigators.
6. Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
7. Strong communication skills with the ability to work in a cross functional and global organization.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $152,600 and $283,400/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more here.

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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 & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Division Development

Business Unit Innovative Medicines

Location USA

State New Jersey

Site East Hanover

Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation