Associate Clinical Development Director, Gene Therapy

Legend Biotech USA; East Hanover (NJ); On-site; USD 150,000 - 200,000; Full time

Job summary

An established industry player is seeking a Clinical Development Director to lead the scientific and clinical strategy for clinical trials within their Gene Therapies team. This pivotal role involves overseeing protocol development, ensuring quality data reporting, and providing strategic input for clinical documents. The ideal candidate will have significant experience in clinical research and drug development, with a strong background in life sciences. Join a mission-driven organization that values innovation and collaboration, and be part of a team dedicated to reimagining medicine and improving lives.

Qualifications

• 3+ years in clinical research or drug development required.
• Strong communication and negotiation skills are essential.

Responsibilities

• Lead scientific and clinical strategy for clinical trials.
• Contribute to protocol development and regulatory documents.

Skills

Clinical Research

Drug Development

Communication Skills

Negotiation Skills

Conflict Resolution

Education

PharmD

PhD

Advanced degree in life sciences/healthcare

Tools

GCP

Clinical Trial Design

Statistics

Job description

Job Description Summary

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.

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).

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).

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!

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] 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.

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.