Global Head of Clinical Development
About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history.
As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine.
Our purpose is to fuel confidence by helping people look better, feel better, and live better.
We believe you do not have to choose between living life and making a living.
Live your best life with Merz Aesthetics.
A brief Summary
Serves a key role within the Merz Aesthetics Clinical Research and Development team, the Global Head of Clinical Development will be responsible for the development and implementation of clinical strategies for new innovative medical devices and new substances across the US and EU Clinical Development teams.
Accountability for clinical aspects of Product Development from early evaluation through design and conduct of clinical studies, post-market studies, clinical research projects to register new products and indications in key countries, and maintenance of approved products.
Essential Duties and Responsibilities
* Accountable for definition of clinical development strategy and development of clinical trial design:
+ Develops overall medical and clinical global strategy for the clinical development of new substances/devices/indications in close collaboration with other R&D functions and EMEA Clinical Development
+ Develops clinical trial design in close collaboration with other functions and, whenever needed, with external experts
* Accountable for delivering high quality and timely documents (may be document owner or significant contributor):
+ Develops overall medical and clinical global strategy for the clinical development of new substances/devices/indications in close collaboration with other R&D functions and EMEA Clinical Development
+ Develops clinical trial design in close collaboration with other functions and, whenever needed, with external experts
* Accountable for providing expertise to facilitate the trial set-up and conduct of clinical studies, including interpretation and reporting of study data:
+ Collaborates within a multidisciplinary team in the preparation of trial related documents (Investigator’s meeting, Informed Consent Form, Case Report Form etc.)
+ Accountable for ongoing review of in-life trial data including protocol deviations (if applicable, establishes Data Monitoring Committee)
+ Provides input to Final Statistical Plan
+ Accountable for appropriate interpretation of study data and study results (tables, figures and listings) and creation of main messages
+ Accountable for development and validation of aesthetic photonumeric scales (where appropriate)
* Accountable for clinical input to regulatory activities:
+ Accountable for clinical parts of regul...
- Rate: Not Specified
- Location: Raleigh, US-NC
- Type: Permanent
- Industry: Science
- Recruiter: Merz North America, Inc
- Contact: Not Specified
- Email: to view click here
- Reference: GLOBA003916
- Posted: 2025-01-13 07:39:18 -
- View all Jobs from Merz North America, Inc
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