Jobs in Bologna, United States

Please 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, supporting Glenmark’s objectives across markets. Responsibilities include strategic and tactical clinical leadership for evaluating and planning clinical development programs, protocol development, trial execution, regulatory interactions for registration trials, and lifecycle management of dermatology products. The role involves reviewing scientific data, performing due diligence for in-licensing, and acting as a conduit between internal teams and external stakeholders throughout product development.

The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets, familiar with regulators such as the EU and USFDA.

Responsibilities:

1. 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. Oversee medical monitoring of dermatology clinical studies.
4. Build partnerships with dermatology stakeholders, external experts, and health professionals to foster scientific understanding and advocacy.
5. Support global medical affairs in due diligence for licensing and acquisition of new products.
6. Plan and coordinate dissemination of data through publications, conferences, and journals.
7. Ensure compliance with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

1. Medical degree (MD or equivalent) in dermatology with 10-12 years of experience in clinical sciences, regulatory registration studies, or clinical development in pharma/biotech sectors.
2. Understanding of drug development processes and regulatory pathways in dermatology across markets.
3. Ability to interpret complex clinical data and communicate effectively.
4. Experience working in cross-functional, matrix organizations, with skills in resource and financial management.