Associate Clinical Development Director, Gene Therapy

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

Job summary

An established industry player is seeking a Clinical Development Director to lead scientific and clinical strategies for innovative gene therapies. This pivotal role involves overseeing clinical trials, contributing to protocol development, and ensuring high-quality data reporting. The ideal candidate will have a strong background in clinical research and drug development, along with excellent communication and leadership skills. Join a dynamic team dedicated to advancing healthcare solutions and making a meaningful impact on patients' lives. This is an exciting opportunity to be at the forefront of medical innovation and drive significant change in the field.

Benefits

401(k) eligibility

Paid time off

Medical benefits

Discretionary awards

Sign-on bonus

Restricted stock units

Qualifications

• 3+ years in clinical research or drug development.
• Strong communication skills, written and oral.
• Working knowledge of GCP and clinical trial design.

Responsibilities

• Lead clinical and scientific strategy for clinical trials.
• Develop trial-related documents and regulatory submissions.
• Contribute to talent development and coaching of associates.

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

PhD

Advanced degree in life sciences/healthcare

Job description

Job Description Summary

Onsite
#LI-Onsite
East Hanover, New Jersey

About the role:
We have an exciting opportunity as a Clinical Development Director in our Gene Therapies team. In this role, you will lead the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data and clinical and scientific strategy of assigned sections of a clinical development program.

The Associate Clinical Development Director (Assoc. CDD) is a key role that contributes to protocol development for global clinical trials, scientific monitoring, and data reporting. They may support the clinical and scientific strategy of sections within a clinical development program, based on its size and complexity.

Job Description

Your Key Responsibilities:

• Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents for assigned clinical trials consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for Novartis local medical organizations. Lead development of clinical sections of trial and program level regulatory documents.
• Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents, safety updates, submission dossiers, and responses to Health Authorities
• Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
• May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities
• Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members
• *Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
• Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
  

Video Link https://www.youtube.com/watch?v=ggbnzRY9z8w

The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position may require 5% travel.

Role Requirements:
Essential Requirements:

• PharmD, or PhD strongly preferred. Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
• 3+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• 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
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Strong communication skills, written and oral
• Excellent negotiation, conflict resolution and communication skills (written and oral).

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:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https://www.novartis.com/careers/benefits-rewards

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 in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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