Requirements: English
Company: Glenmark Pharmaceuticals
Region: italy, it ,
Pls note: Incumbent can be based anywhere in Europe orthe US. Role Overview: This position is intended to head andsupport the clinical development of new drugs conception ofinnovative approaches to plan clinical studies and support end toend drug development in accordance with all applicable regulationsand align them with company''s business objectives. Discussions withglobal regulators on respiratory clinical development pathways forfacilitation of drug approvals; review & due diligence ofin-licensing respiratory molecules; presentation in in ad boardsand global respiratory meetings. Job Responsibilities: - Lead,manage and mentor Clinical Sciences respiratory projects and ensuretimely delivery of all deliverables. The responsibilities of theGlenmark Medical Monitor may include but is not limited to thefollowing: - Contribute and/or provide review to key study relateddocuments such as protocols, informed consents and amendments,eCRFs, SAP, MMP, SMP, and TLFs - Review of CRO medical monitoringcapabilities as part of study start up and RFP process includingthe CRO MM CVs, MMP, and investigator/site lists as part of thevendor selection process or final CRO determination - Provideguidance on subject eligibility, deviations, and other medical,safety, or protocol related questions to CRO MM, siteinvestigators, and CRO and Sponsor study team - Review of blindedefficacy and safety data, listings, tables, deviations, and providesupportive review of blinded SAE or SUSAR related documents andaddress or escalate any data that might impact subject safety orstudy integrity - Attendance during internal or joint CRO-sponsormedical monitoring safety meetings and review of medical meetingminutes. - Review of blinded medical coding for AEs, SAEs, priorand concomitant medications, and medical history, and participatein BDRM prior to DBL and provide primary interpretation of efficacyand safety after unblinding. - Support Business development forrespiratory programs and portfolio, med affairs in BD and ROWdevelopment including new and lifecycle management programs. -Build and maintain close collaboration with internal stakeholders(Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps,Project Management, Medical Affairs, legal and others). Participatein ad boards, respiratory forums, presentations in respiratorymeetings. Discussions with regulators on clinical developmentpathways and faster approvals. - Development of projects andevaluation of new business opportunities or internal Target DrugCandidates for expansion of respiratory, allergy, and inflammationpipeline and business growth. Drive the overall strategy anddelivery of respiratory programs from clinical candidate evaluationand selection up to Registration. Knowledge and Education:Educational Qualifications: - MD / MS - MD Internal andPulmonary/Critical Care Medicine Experience: - Minimum 18 yearsexperience as a practicing pulmonary clinical professional with>5 years experience in the pharmaceutical industry/ clinicalprojects in clinical development; regulatory interactions for drugdevelopment Knowledge and Skills (Functional / Technical): - DrugDevelopment - Scientific advocacy with policymakers/regulatorsBehavioural Attributes: - The incumbent should be good atdecision-making and influencing the team. Should have goodInterpersonal skills.