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Sr Clinical Development Director - Cardio Renal Metabolic

Business Development



East Hanover, New Jersey, United States

INTERNAL ROLE TITLE: SENIOR CLINICAL DEVELOPMENT DIRECTOR <br><br>LOCATION: EAST HANOVER, NJ<br><br>ABOUT THIS ROLE:<br>Novartis is deeply committed to transforming the lives of people living with cardiovascular, renal and metabolic diseases. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.<br><br>Our mission is to reimagine medicine to extend and improve people’s lives – and our overall company strategy to achieve this is to focus Novartis as a leading medicine company powered by data science and advanced therapy platforms.<br><br>The Senior Clinical Development Director (Sr. CDD), Business Development & Licensing (BD&L) and Early programs, in the Cardio Renal Metabolic (CRM) Development Unit (DU) is the clinical due diligence leader and clinical (Global Drug Development) representative for select early programs. <br><br>As a Sr. CDD, you may also lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase) or a large, complex trial, under the leadership of the Sr. Global Program Clinical Head (GPCH). The Sr. CDD may also lead clinical programs, depending on the size, nature and complexity. <br><br><br>KEY RESPONSIBILITIES:<br>• Work with BD&L to lead the clinical evaluation of due diligences in close collaboration with other line functions<br>• Work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point)<br>• Support the Clinical Development Head (CDH) by acting as lead reviewer at Integrated Scientific Review Committee meetings and providing clinical/scientific input into clinical trial protocol reviews and contributing in/driving development of disease clinical standards for new disease areas. May take on DU responsibilities as directed by the Clinical Development Head (CDH)<br>• As a clinical expert, support the GPCH or CDH in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal collaborators (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and internal decision boards<br>• Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)<br>• Provide clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program or programs. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review program specific standards, clinical components of regulatory documents/registration dossiers, and publications<br>• Drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates<br>• Ensure ongoing medical and scientific review of clinical trial data<br>• Support (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and supports overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, and other safety related documents) in collaboration with Patient Safety<br>• Lead the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when needed in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as needed<br>• Contribute to medical/scientific training of relevant Novartis collaborators on the disease area and compound/molecule. May serve as speaker for DU medical/ scientific training<br>• May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)<br><br>The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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 sign-on 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 “at-will 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. <br><br>[#video#{#400,300#}#/video#]