(Senior) Clinical Development Medical Director - Rheumatology
Company: Novartis Group Companies
Location: East Hanover
Posted on: October 23, 2024
Job Description:
Job Description SummaryAs a Clinical Development Medical
Director in our Immunology Development Unit you will be responsible
for the scientific and clinical strategy of assigned clinical
trials, scientific monitoring, and reporting of quality data.
The Clinical Development Medical Director (CDMD) is the clinical
leader of defined program level activities (e.g., submission
activities, briefing books, clinical study reports, etc.) and/or a
large, complex trial, under the leadership of the Global Program
Clinical Head (GPCH). May also lead a section of a clinical program
(e.g., an indication, a new formulation, or a specific development
phase).
Job DescriptionMajor accountabilities:
- Provide clinical leadership and medical strategic input for
deliverables in the assigned project/program. Deliverables may
include sections of individual protocols consistent with the
clinical development plan (CDP), data review, program specific
standards, clinical components of regulatory documents/registration
dossiers, and publications (e.g., investigator brochures, briefing
books, safety updates, submission dossiers, and responses to health
authorities)
- * Drive execution of the section of the program in partnership
with global line functions, assigned Global Trial Directors, and
regional/country medical associates
- * Oversee/conduct medical and scientific review of trial data
with Clinical Scientific Expert (CSE). May be the Program Manager
of other associates (e.g.., CSE). May function as study medical
monitor
- * Support GPCH in ensuring overall safety of the molecule. May
be a core member of the Safety Management Team, and supports
program safety reporting (e.g., PSURs, DSURs, and safety related
documents) in collaboration with Patient Safety
- * Support the Clinical Development Head by providing medical
input into CDP and clinical trial package reviews and
contributing/driving development of disease clinical standards for
disease areas
- * Provide support to the GPCH or CDH in interactions with
external partners (e.g., regulatory authorities, key opinion
leaders, data monitoring boards, advisory boards, patient advocacy
groups), internal partners (e.g., clinical trial team, Medical
Affairs, Commercial, Health Economics & Outcomes Research), and
decision boards)
- * Work with NIBR (Novartis Institute of Biomedical
Research)/Translational Medicine) to drive transition of early
development projects to Transition Decision Point and with Business
Development, including target identification and due
diligences
- * Ensure career development of Program Reports and clinical
colleagues through active participation in performance management
and talent planning processes. Provide on-boarding, training, &
mentoring support
- Contribute to medical/scientific training of relevant Novartis
stakeholders on the disease area and compound/molecule. May serve
as speaker for Global Clinical team
- May serve on or lead global initiatives (e.g., process
improvement, training, SOP development, other Clinical Development
line function initiatives)Minimal Requirements:
- MD (or equivalent medical degree) required. Training in
Immunology/Rheumatology/Dermatology preferred
- Medical Board certification preferred. 4+ years Clinical
practice experience (including residency) preferred
- Possess advanced knowledge and clinical training in a
medical/scientific area (e.g., internal medicine or sub-specialty)
required
- 5+ years of experience in clinical research or drug development
from the pharmaceutical/biotechnology industry, preferably spanning
clinical activities in phases I through IV
- 3+ years of contribution to and accomplishment in all aspects
of conducting clinical trials (e.g., planning, executing,
reporting, and publishing) in a global/matrixed environment
- Showcase advanced knowledge of assigned therapeutic area
- Demonstrate ability to establish strong scientific partnership
with key partners
- Need thorough knowledge of Good Clinical Practice, clinical
trial design, statistical analysis methodology, and
regulatory/clinical development processes
- People management experience preferred, especially at the
global level (this may include management in a matrixed
environment)
- Exhibit excellent business communication and presentation
skills
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 accommodationsThe 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 tas.nacomms@novartis.com 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range$257,600.00 - $386,400.00
Skills Desired
Keywords: Novartis Group Companies, Westport , (Senior) Clinical Development Medical Director - Rheumatology, Executive , East Hanover, Connecticut
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