(Senior) Clinical Development Director
(Senior) Clinical Development Director
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$ 204400 - 379600
1 Vacancy
Job Description
Band
Level 6Job 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 endtoend 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 clinical leadership and 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 and may be the Program Manager of other associates
Work Experience:
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD or PhD strongly preferred
10 years of involvement in clinical research global drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 5 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. Experience in late phase clinical development strongly preferred
Solid scientific writing skills
Experience with regulatory submissions (IND NDA/BLA CTA/MAA) preferred
Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data. Strong affinity with data data quality and analysis.
Preferred knowledge and/or experience of assigned therapeutic area
Demonstrated ability to establish strong scientific partnership with key internal and external stakeholders
3 years people management experience required; this may include management in a matrix environment*
Final job title Senior Clinical Development Director / Clinical Development Director and associated responsibilities will be commensurate with the successful candidates level of expertise.
Novartis Compensation and Benefit Summary:The pay range for this position at commencement of employment is expected to be between: $204400and $379600/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market maynecessitateadjustments to pay ranges during this final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and 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 tomodifybase 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 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 call 1 (877)and 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 Trials Coaching CrossFunctional Teams Lifesciences People Management Risk Management Risk MonitoringRequired Experience:
Director
Employment Type
Full-Time
