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(Senior) Clinical Development Medical Director
(Senior) Clinical Development Medical DirectorNovartis Group Companies • East Hanover, NJ, United States
(Senior) Clinical Development Medical Director

(Senior) Clinical Development Medical Director

Novartis Group Companies • East Hanover, NJ, United States
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Job Description Summary

The (Senior) Clinical Development Medical Director -Leads the strategic and operational planning and management of the assigned clinical program(s) from an end-to-end clinical operations perspective. The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As CDMD in the Renal TA, you will have oversight of the clinical development for the assigned programs and drive 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

Job Description

Your responsibilities will include, but are not limited to :

  • Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
  • Leading development of clinical sections of trial and program level regulatory documents
  • Driving execution the assigned clinical program and / or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional / country medical associates, where applicable
  • Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
  • Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to / driving development of disease clinical standards for new disease areas
  • As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
  • May work with 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.

What you bring to the role :

  • MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical / scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred
  • Minimum of 7 years of experience in clinical research or drug development
  • Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
  • 2 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 required.
  • Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
  • Demonstrated ability to establish effective scientific partnerships with key stakeholders
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
  • Previous global people management experience is preferred, though this may include management in a matrix environment.
  • Novartis Compensation and Benefit Summary : The pay range for this position at commencement of employment is expected to be between : $236,400 and $439,600 / year; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 25, 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.

    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 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Salary Range

    $236,600.00 - $439,400.00

    Skills Desired

    Clinical Trials, Cross-Functional Teams, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Research, Medical Strategy, People Management

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    Director Development • East Hanover, NJ, United States

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