Director/ Sr Director/ Executive Director- Clinical Development (Dermatology)
Note: Incumbent can be based anywhere in Europe or the US.
The Clinical Sciences/Clinical Development Director for dermatology shall provide high-level clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, aligning with Glenmark’s objectives across various markets. The role involves strategic and tactical clinical leadership for evaluating and planning clinical development programs, protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products. Additionally, the person will review scientific data, perform due diligence for in-licensing potential assets, and serve as a conduit between internal and external stakeholders throughout product development and lifecycle management. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators such as EU/USFDA.
Job Responsibilities:
1. Critically evaluate clinical data of investigational and similar drugs to inform development strategies.
2. Collaborate with Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Medical Affairs, and Intellectual Property teams for planning, protocol development, execution, and regulatory interactions.
3. Provide medical monitoring and supervision for dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to foster scientific understanding and advocacy.
5. Work with global medical affairs to evaluate licensing and acquisition opportunities for late-stage and marketed dermatology products.
6. Plan and oversee publication and presentation of data at conferences, symposia, and journals.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.
Knowledge and Experience:
* MD or equivalent postgraduate degree in dermatology.
* Approximately 10-12 years of experience in clinical sciences, regulatory registration studies, or Phase 1-3 clinical development in pharmaceutical/biopharmaceutical companies.
* Understanding of drug development processes and regulatory pathways for dermatology products globally.
* Ability to evaluate, interpret, and present complex clinical trial data.
* Experience working in cross-functional teams within a matrix organization.
* Experience in financial/resource planning and management.
* Excellent communication and presentation skills, with the ability to meet scientific and commercial needs.
* Ability to coordinate with multiple stakeholders across geographies.
#J-18808-Ljbffr