Legend Biotech USA
Senior Clinical Development Director - Renal
Legend Biotech USA, East Hanover, New Jersey, us, 07936
Overview
The Senior/Clinical Development Director (Sr*CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial. This may involve an indication, a new formulation, a specific development phase, or a large, complex trial. The Sr*CDD may be assigned to lead a team for sections of clinical programs and/or global clinical trials, depending on size, nature, and complexity, under the leadership of the GPCH. Job Description Major accountabilities
Supports and, if assigned, leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols aligned with the Integrated Development Plans (IDP), clinical data review program-specific standards, clinical components of regulatory documents/registration dossiers, and publications. Contributes and, if assigned, leads development and delivery of clinical sections of trial and program-level regulatory documents (e.g., Investigators’ Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities). Drives execution of the section of the clinical program in partnership with global line functions, particularly clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates. Ensures ongoing clinical and scientific review of clinical trial data. Works with data management and statistics teams to ensure data quality and appropriate analysis of clinical trial results. May be the Program or Function Manager of associates (e.g., CDD or associate CDD). Supports GPCH in assessing overall risk-benefit of the molecule for the assigned section of the clinical program; may be a core member of the Safety Management Team (SMT) and supports overall program safety reporting (e.g., PSURs, DSURs, and other safety-related documents) in collaboration with the medical monitor, CDMD and Patient Safety. Member and, if assigned, may (co-)lead the Global Clinical Team (GCT); represents the section in Global Program Team (GPT) meetings and serves as the section spokesperson in internal and external meetings/boards, as assigned. Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the CDH. Minimum Requirements
Work Experience: Advanced degree in life sciences/healthcare (or clinically relevant degree) required. PharmD or PhD strongly preferred. ≥ 10 years of involvement in clinical research and global drug development in academic or industry settings, spanning Phases I–IV. ≥ 5 years of contribution to all aspects of conducting clinical trials (planning, executing, reporting, publishing) in a global/matrix pharmaceutical environment; late-phase development 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; emphasis on data quality and analysis. Preferred knowledge or experience in the assigned therapeutic area. Demonstrated ability to establish strong scientific partnerships with key internal and external stakeholders. ≥ 3 years of people management experience required; may include management in a matrix environment. Final job title Senior Clinical Development Director, Level 6 / Clinical Development Director, Level 6, and associated responsibilities will be commensurate with the successful candidate’s level of expertise. Compensation and Benefits
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $204,400 and $379,600/year; however, salary ranges are effective from 1/1/25 through 12/31/25, and may be adjusted due to market factors. Final pay determinations depend on factors including location, experience, knowledge, skills, and abilities. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full range of benefits (including 401(k), paid time off, etc.). Details will be provided if an offer is made. Employment is at-will and the Company reserves the right to modify base salary and other compensation programs at any time. Diversity, Equity & Inclusion
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers focused on building a culture of inclusion. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve. Accessibility
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and include the job requisition number in your message. 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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The Senior/Clinical Development Director (Sr*CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial. This may involve an indication, a new formulation, a specific development phase, or a large, complex trial. The Sr*CDD may be assigned to lead a team for sections of clinical programs and/or global clinical trials, depending on size, nature, and complexity, under the leadership of the GPCH. Job Description Major accountabilities
Supports and, if assigned, leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols aligned with the Integrated Development Plans (IDP), clinical data review program-specific standards, clinical components of regulatory documents/registration dossiers, and publications. Contributes and, if assigned, leads development and delivery of clinical sections of trial and program-level regulatory documents (e.g., Investigators’ Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities). Drives execution of the section of the clinical program in partnership with global line functions, particularly clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates. Ensures ongoing clinical and scientific review of clinical trial data. Works with data management and statistics teams to ensure data quality and appropriate analysis of clinical trial results. May be the Program or Function Manager of associates (e.g., CDD or associate CDD). Supports GPCH in assessing overall risk-benefit of the molecule for the assigned section of the clinical program; may be a core member of the Safety Management Team (SMT) and supports overall program safety reporting (e.g., PSURs, DSURs, and other safety-related documents) in collaboration with the medical monitor, CDMD and Patient Safety. Member and, if assigned, may (co-)lead the Global Clinical Team (GCT); represents the section in Global Program Team (GPT) meetings and serves as the section spokesperson in internal and external meetings/boards, as assigned. Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the CDH. Minimum Requirements
Work Experience: Advanced degree in life sciences/healthcare (or clinically relevant degree) required. PharmD or PhD strongly preferred. ≥ 10 years of involvement in clinical research and global drug development in academic or industry settings, spanning Phases I–IV. ≥ 5 years of contribution to all aspects of conducting clinical trials (planning, executing, reporting, publishing) in a global/matrix pharmaceutical environment; late-phase development 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; emphasis on data quality and analysis. Preferred knowledge or experience in the assigned therapeutic area. Demonstrated ability to establish strong scientific partnerships with key internal and external stakeholders. ≥ 3 years of people management experience required; may include management in a matrix environment. Final job title Senior Clinical Development Director, Level 6 / Clinical Development Director, Level 6, and associated responsibilities will be commensurate with the successful candidate’s level of expertise. Compensation and Benefits
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $204,400 and $379,600/year; however, salary ranges are effective from 1/1/25 through 12/31/25, and may be adjusted due to market factors. Final pay determinations depend on factors including location, experience, knowledge, skills, and abilities. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full range of benefits (including 401(k), paid time off, etc.). Details will be provided if an offer is made. Employment is at-will and the Company reserves the right to modify base salary and other compensation programs at any time. Diversity, Equity & Inclusion
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers focused on building a culture of inclusion. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve. Accessibility
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and include the job requisition number in your message. 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
#J-18808-Ljbffr