Pls note : Incumbent can be based anywhere in Europe or the US.
Role Overview:
This position is intended to head and support the clinical development of new drugs conception of innovative approaches to plan clinical studies and support end to end drug development in accordance with all applicable regulations and align them with company's business objectives. Discussions with global regulators on respiratory clinical development pathways for facilitation of drug approvals; review & due diligence of in-licensing respiratory molecules; presentation in in ad boards and global respiratory meetings.
Job Responsibilities:
* Lead, manage and mentor Clinical Sciences respiratory projects and ensure timely delivery of all deliverables. The responsibilities of the Glenmark Medical Monitor may include but is not limited to the following:
* Contribute and/or provide review to key study related documents such as protocols, informed consents and amendments, eCRFs, SAP, MMP, SMP, and TLFs
* Review of CRO medical monitoring capabilities as part of study start up and RFP process including the CRO MM CVs, MMP, and investigator/site lists as part of the vendor selection process or final CRO determination
* Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol related questions to CRO MM, site investigators, and CRO and Sponsor study team
* Review of blinded efficacy and safety data, listings, tables, deviations, and provide supportive review of blinded SAE or SUSAR related documents and address or escalate any data that might impact subject safety or study integrity
* Attendance during internal or joint CRO-sponsor medical monitoring safety meetings and review of medical meeting minutes.
* Review of blinded medical coding for AEs, SAEs, prior and concomitant medications, and medical history, and participate in BDRM prior to DBL and provide primary interpretation of efficacy and safety after unblinding.
* Support Business development for respiratory programs and portfolio, med affairs in BD and ROW development 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). Participate in ad boards, respiratory forums, presentations in respiratory meetings. Discussions with regulators on clinical development pathways and faster approvals.
* Development of projects and evaluation of new business opportunities or internal Target Drug Candidates for expansion of respiratory, allergy, and inflammation pipeline and business growth. Drive the overall strategy and delivery of respiratory programs from clinical candidate evaluation and selection up to Registration.
Knowledge and Education:
Educational Qualifications:
* MD / MS
* MD Internal and Pulmonary/Critical Care Medicine
Experience:
* Minimum 18 years experience as a practicing pulmonary clinical professional with> 5 years experience in the pharmaceutical industry/ clinical projects in clinical development; regulatory interactions for drug development
Knowledge and Skills (Functional / Technical):
* Drug Development
* Scientific advocacy with policymakers/regulators
Behavioural Attributes:
* The incumbent should be good at decision-making and influencing the team. Should have good Interpersonal skills.