Senior Clinical Development Medical Director - Cardio | Renal | Metabolism

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Job Description Summary

Job Description

Major accountabilities:

• Provides 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 (IDP) clinical data review program specific standards clinical components of regulatory documents/registration dossiers and publications

• Leads development 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 assigned study leads (SLs) and regional/country medical associates

• Ensures ongoing medical and scientific review of clinical trial data

• Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section may be a core member of the Safety Management Team (SMT) and supports overall program safety reporting (e.g. Periodic Safety Update Reports (PSURs) Drug Safety Update Reports (DSURs) and other safety related documents) in collaboration with Patient Safety

• Leads 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

• Supports the Clinical Development Head (CDH) by providing medical input into IDP 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

• As a medical expert supports the (Sr.) GPCH or CDH in interactions with external stakeholders (e.g. regulatory authorities key opinion leaders data monitoring boards advisory boards patient advocacy groups) internal stakeholders (e.g. CTT Research Translational Medicine Global Medical Affairs Marketing HE&OR) and internal decision boards

• May 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) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters as needed

• Ensures career development of Function and Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding training & mentoring support

• 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

• May serve on or lead global initiatives (e.g. process improvement training SOP development other Clinical Development line function initiatives)

• Specific responsibilities related to the clinical program in CRM include:

• Serving as the lead medical for a pivotal registration trial (CV outcomes study)

• Leading the clinical work related to an NDA submission

• Coach and support junior clinical team members through the submission phase

Minimum Requirements:

• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g. internal medicine or sub-specialty) required with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred

• Fluent oral and written English

• 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I IV

• 4 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

• NDA submission experience with major health authorities (FDA and EMA)

• Advanced knowledge of assigned therapeutic area

• Demonstrated ability to establish strong scientific partnership with key stakeholders

• Thorough knowledge of GCP clinical trial design statistical analysis methodology and regulatory/clinical development process

• Excellent communication skills written and oral

• Strong interpersonal skills

• Excellent negotiation and conflict resolution skills

Novartis Compensation and Benefit Summary:The pay range for this position at commencement of employment is expected to be between: $236600 - $439400; 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 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 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.

Commitment to Diversity & Inclusion:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams representative of the patients and communities we serve and 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 e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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