Associate Clinical Development Director Gene Therapy
Associate Clinical Development Director Gene Therapy
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$ 152600 - 283400
1 Vacancy
Job Description
Band
Level 5Job Description Summary
Onsite#LIOnsite
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 trialrelated 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 peerreview 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 onboarding 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).
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $152600 and $283400/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 signon 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 atwill 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 peoples 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: receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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: 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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Budget Management Clinical Research Clinical Trial Protocol Clinical Trials Coaching CrossFunctional Teams Data Analysis Learning Design Lifesciences Risk Management Risk MonitoringRequired Experience:
Director
Employment Type
Full-Time
