Associate Clinical Development Director

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

Job summary

Join a forward-thinking company as a Clinical Development Director, where you will lead strategic planning and execution of clinical programs in the Cardio Renal & Metabolic Development Unit. This role offers the opportunity to oversee clinical development, ensuring the highest standards of safety and efficacy in drug development. Collaborate with global teams and contribute to scientific training while making a significant impact in the healthcare sector. If you have a passion for clinical research and a strong background in life sciences, this is your chance to thrive in a dynamic environment.

Benefits

401(k) eligibility

Paid time off benefits

Medical insurance

Discretionary awards

Sign-on bonus

Restricted stock units

Qualifications

• Advanced degree in life sciences or clinically relevant degree required.
• Minimum 7 years experience in clinical research or drug development.

Responsibilities

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

Skills

Budget Management

Clinical Research

Clinical Trial Protocol

Clinical Trials

Coaching

Cross-Functional Teams

Data Analysis

Learning Design

Lifesciences

Risk Management

Risk Monitoring

Education

PharmD or PhD in life sciences

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 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.

Job Description

Major Accountabilities

* 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
* Leading development of clinical sections of trial and program level regulatory documents
* 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
* Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
* 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
* As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
* 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:

* Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred***
* Fluent oral and written English
* Minimum 7 years experience in clinical research or drug development
* 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
* Demonstrated ability to establish effective working relationship with key investigators
* Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
* 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.

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

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.

Salary Range

$152,600.00 - $283,400.00

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring