Glenmark is hiring DGM / GM Clinical Development

Position:DGM / GM Clinical Development

Location: Mumbai

Job Nature: On-site Full-time Mid-Senior level

Skills: Clinical Data, Clinical Development, Drug Development, Oncology, and Oncology Clinical Research

Job Role : The Clinical Development incumbent will be responsible for the oversight of development and execution linked to worldwide clinical development plans for the assigned programs in portfolio focussed on Oncology and innovative in-licensed assets. The incumbent will be responsible for integrating clinical development objectives with global considerations into strategic business decisions. The incumbent will ensure clinical, operational and medical governance excellence across all clinical development projects for the assigned programs.

Overall Job Responsibilities :

Contribute to the medicine development strategy in Oncology and assure clinical studies are conducted effectively
Lead the clinical study teams in the development and conduct of clinical studies; ensure consistency with clinical development strategy for regulatory approvals and successful lifecycle management
Participation in the interpretation of data analyses of clinical trial results and support development of clinical study reports
Execute Medical monitoring both remote and on site in oncology clinical studies
Lead authoring of study protocols, CRFs and contribute to development of analytical plans; participate in data review discussions and provide clinical/scientific inputs during the development & execution of clinical trials including key observational studies
Accountable for authoring of clinical study reports and Investigator Brochures; assist in creating materials for Investigator meetings
Review standard format data displays in protocols and CRFs to assure consistency in data capture
Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA, BLA, MAA)
Assist with the writing of manuscripts, development & review of abstracts, presentations and manuscripts for accuracy of clinical data and content
Contribute to the establishment of standards for clinical documents and data review processes across clinical development for Oncology
Lead and design content for regulatory presentations & interactions for oncology programs. Lead KoL meetings, DSMB meetings & PI meetings

Experience :

MBBS / MD in Radiation Oncology or Oncology with 5 – 10 years of experience in drug development

Interested candidates can share profiles on divya.tulsyan@glenmarkpharma.com

or can Apply Here: https://www.linkedin.com/jobs/view/3922618904/?alternateChannel=search&refId=L6jWZNrGs0vU8nzlQWJS2w%3D%3D&trackingId=sWLh25D6CdEE0FAK8fipYw%3D%3D#HYM