Requirements: English
Company: Glenmark Pharmaceuticals
Region: Monza , Lombardy
Please Note: Incumbent can be based anywhere in Europeor US The Clinical Sciences/Clinical Development Director fordermatology shall be responsible to provide a high level ofclinical expertise in the area of Dermatology from thepre-registration stage to the commercialization of the innovativeproducts to achieve Glenmarks objective in various markets. Theperson shall be responsible to provide strategic & tacticalclinical leadership to enable successful evaluation and planning ofclinical development program, protocol preparation, trial executionfrom a medical perspective and regulatory interactions forregistration clinical trials and life cycle management ofinnovative, speciality dermatology products across various markets.Additionally, the person shall review scientific data and performdue diligence for in-licensing of potential assets. The personshall act as the conduit between multiple internal as well asexternal stakeholders throughout the development and life cycle ofthe products in various markets. The person should be a traineddermatologist with experience working in clinical sciences/clinicaldevelopment for registration assets and having experience workingwith various regulators including EU/USFDA, etc. JobResponsibility: - Critical evaluation of clinical data of theinvestigational products, similar drugs from clinical sciencesperspective to build a foundation for clinical developmentstrategies for registrational purposes. - Closely collaborates withvarious teams (including Clinical Development team members, ProjectManagement , Clinical Operations, Pharmacovigilance, Regulatory,Global Medical Affairs, Intellectual Property) for clinicaldevelopment planning, protocol development & finalization,execution support, regulatory presentations and approvalsinteractions, etc. - Medical monitoring and supervision of theclinical dermatology studies - Develops and maintains collaborativepartnerships with dermatology stakeholders, key external experts,and allied health professionals ensuring scientific understandingand advocacy around products and therapeutic area - Global medicalaffairs team to provide medical / scientific expertise on duediligence of new product licensing and acquisition opportunitiesfor late-stage compounds and marketed products. - Planspublication/presentation of data in international conferences,scientific symposias, etc and/or journals in line with theclinical data generated - Ensures that all activities are carriedout in compliance with Glenmark standards, standard operatingprocedures and external regulations Knowledge and Experience: -Medical educational background (MD or equivalent post graduatemedical degree) in dermatology with an approximate experience of 10to 12 years of working in clinical sciences, regulatoryregistration dermatology studies or Phase 1- Phase 3 clinicaldevelopment function of pharmaceutical /biopharmaceuticalcompanies. Understanding of the overall drug development processand regulatory path for dermatology products in various markets.Able to evaluate, interpret and present highly complex data fromclinical trials. Ability to work in cross functional groups andteams with a complex matrix organization. Experience of financialand resource planning and management is essential. Excellentpresentation and communication skills with an ability to meet thescientific, commercial needs. Ability to co-ordinate with multiplestakeholders across Glenmark geographies of various markets bothwithin and outside the organization.