Job Description

We are hiring Aurigene Oncology Limited

Manager/Sr. Manager – Clinical Development Lead
▪️ MBBS, MD in clinical pharmacology with 2-6 years of exp in supporting & managing NCE/NBE clinical development programs
▪️ Clinical development experience (in the pharmaceutical or CRO environment) related to the design &/or conduct of NCE/NBE clinical studies in one or more areas of oncology, immune-inflammation, immune-oncology
▪️ Significant exp both as a clinical development leader & as a medical monitor, in the IND, Ph1 & Ph2/PoC settings in the relevant therapeutic areas
▪️ Clinical development experience in Cell & Gene Therapy desired
▪️ Ability to integrate translational research, clinical pharmacology & pharmacokinetic approaches to enable early clinical development
▪️ Strong understanding of relevant regulatory health authority expectations & regulations as it relates to early clinical development & exp of having interfaced with such agencies
▪️ Prior track record of having authored clinical development plans, protocols, investigator brochures, regulatory submissions etc.
▪️ Significant exp in clinical trial budgeting, vendor/CRO ID, contracting & project management
▪️ Proven ability to apply broad multi-disciplinary expertise to problems to arrive at innovative strategies & solutions to support clinical development objectives
▪️ Participate as the clinical program leader on project teams. Develop expertise on specific disease areas of relevance to the program, current clinical practice insights, standard-of-care treatment protocols, diagnosis & prescription patterns across geographies
▪️ Be the clinical lead for Cell & Gene Therapy products. Integrate clinical expertise & market intelligence data towards indication selection & planning for the assigned programs.
▪️ Develop detailed CD plans complete with proposed indication strategy, trial design, regulatory roadmap etc, in collaboration with regulatory, preclinical & CMC teams.
▪️ Work with the project leader & preclinical, DMPK, toxicology, CMC & translational biology team members to draft & integrate relevant parts of the IND, IMPD, Target Product Profile.
▪️ Responsible for drafting & finalizing submission-quality versions of clinical protocols, investigator’s brochures, response to queries & all associated clinical study related submissions for the assigned programs in collaboration with the regulatory affairs & project team members.
▪️ Assess clinical trial capabilities of various vendors across geographies, work with QA & logistics team in identifying optimal clinical trial vendors (trial conduct, insurance, trial monitoring, DSMB, data mgt, reporting, analytical etc) & support the contracting process.
▪️ Develop & forecast clinical trial budgets, track costs and project manage smooth execution of the clinical program within allocation

Interested candidates may share their profile at sushmitha@aurigene.com