Global Clinical Head Role
This role involves leading the strategic planning, execution, and delivery of all global clinical trials across assigned therapeutic areas. The successful candidate will oversee budget and resource allocation within the therapeutic area, ensuring enterprise-level review of resources across teams.
Key responsibilities include:
* Leads the Global Clinical Trial team and represents Clinical Development on the Global Program Team.
* Develops an endorsed Integrated Development Plan in line with the Target Product Profile, designed for successful global regulatory approval and market access for one or multiple treatment indications.
* Creates high-quality clinical components of key documents, including Clinical Trial Protocols, Investigator's Brochures, and Clinical Study Reports, consistent with the IDP and TPP.
* Supports registration, market access, commercialization, and maintenance of product licenses for the compound(s).
* Evaluates drug safety profiles, ensuring continuous evaluation of safety monitoring in clinical studies and signal detection from post-marketing surveillance.
Requirements for the role include:
* MD or equivalent degree (preferred), or PhD, or PharmD degree required.
* 6 years professional experience with MD or equivalent OR 10 years of involvement in clinical research or drug development in an industry environment spanning Phases I through III/IV.
* Immunology disease expertise, ideally experience with Rheumatology/Gastroenterology.
* Advanced knowledge of assigned therapeutic area required, with capability to innovate in clinical development study designs.
* Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process required.
* Experience with submissions and health authorities required.
* Demonstrated ability to establish strong scientific partnerships with key stakeholders.
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation We are committed to working with individuals with disabilities and providing reasonable accommodations as needed.
Benefits This role offers a hybrid work arrangement and opportunities for professional growth and development.
Seniority level Executive
Employment type Full-time
Job function Other
Industries Pharmaceutical Manufacturing
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