Healthcare Businesswomen’s Association
Clinical Development Director - Renal
Healthcare Businesswomen’s Association, Trenton, New Jersey, United States
Overview
Job Description Summary
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit leads strategic planning and end-to-end clinical development for assigned programs. In the Renal TA, provides oversight and drives execution; enables an empowered, matrix-driven organization responsive to business needs. Major accountabilities
Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program, including clinical sections of protocols or sub studies, data review, program standards, clinical components of regulatory documents/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 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 safety reporting 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 Program Manager of other associates Work Experience and Qualifications
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred ≥ 10 years of involvement in clinical research and global drug development in an academic or industry environment spanning Phases I–IV; ≥ 5 years in conducting clinical trials in a global/matrix pharmaceutical environment; late-phase experience strongly preferred Solid scientific writing skills Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred Strong ability to analyze and interpret scientific literature and data; data quality and analysis focus Preferred knowledge/experience in the assigned therapeutic area Demonstrated ability to establish strong scientific partnerships with key stakeholders ≥ 3 years people management experience in a matrix environment Final job title Senior Clinical Development Director / Clinical Development Director and responsibilities commensurate with level of expertise. Compensation and Benefits
The pay range at commencement of employment is expected to be between $204,400 and $379,600/year. Salary ranges are effective from 1/1/25 through 12/31/25 and may be adjusted. Final pay determinations depend on location, experience, knowledge, skills, and abilities. The total compensation package may include a sign-on bonus, RSUs, discretionary awards, and a full range of benefits (including 401(k) and paid time off). Details provided if an offer is made. At-will employment; company may modify base salary and compensation programs at any time. 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
The Novartis Group of Companies are committed to reasonable accommodation. If you need accommodations for the application process or to perform essential job functions, please email us.reasonableaccommodations@novartis.com or call +1-877-395-2339, including the job requisition number. Salary Range
$204,400.00 - $379,600.00 Skills Desired
Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management
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Job Description Summary
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit leads strategic planning and end-to-end clinical development for assigned programs. In the Renal TA, provides oversight and drives execution; enables an empowered, matrix-driven organization responsive to business needs. Major accountabilities
Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program, including clinical sections of protocols or sub studies, data review, program standards, clinical components of regulatory documents/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 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 safety reporting 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 Program Manager of other associates Work Experience and Qualifications
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred ≥ 10 years of involvement in clinical research and global drug development in an academic or industry environment spanning Phases I–IV; ≥ 5 years in conducting clinical trials in a global/matrix pharmaceutical environment; late-phase experience strongly preferred Solid scientific writing skills Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred Strong ability to analyze and interpret scientific literature and data; data quality and analysis focus Preferred knowledge/experience in the assigned therapeutic area Demonstrated ability to establish strong scientific partnerships with key stakeholders ≥ 3 years people management experience in a matrix environment Final job title Senior Clinical Development Director / Clinical Development Director and responsibilities commensurate with level of expertise. Compensation and Benefits
The pay range at commencement of employment is expected to be between $204,400 and $379,600/year. Salary ranges are effective from 1/1/25 through 12/31/25 and may be adjusted. Final pay determinations depend on location, experience, knowledge, skills, and abilities. The total compensation package may include a sign-on bonus, RSUs, discretionary awards, and a full range of benefits (including 401(k) and paid time off). Details provided if an offer is made. At-will employment; company may modify base salary and compensation programs at any time. 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
The Novartis Group of Companies are committed to reasonable accommodation. If you need accommodations for the application process or to perform essential job functions, please email us.reasonableaccommodations@novartis.com or call +1-877-395-2339, including the job requisition number. Salary Range
$204,400.00 - $379,600.00 Skills Desired
Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management
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