DGM / GM Clinical Development

Role Overview :

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

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