Job Requirements:

• Masters in Clinical Research/PG Diploma in Clinical Research
• 3+ years of extensive, hands-on clinical trial and/or clinical settings of sponsor product
• Experience with international and domestic regulatory submission, oncology experience, clinical trial experience

• To build a good understanding of the Indian oncology space, cancer-site-specific patient burdens, operational details of the CART treatment and patient requirements.
• To maintain and expand on partnerships with clinical team members of treatment centers, their administration, and auxiliary personnel – with the goal of providing expanded access to CAR-T therapies to patients and ensuring smooth clinical operations.
• Maintain awareness of current state of cell & gene therapy (literature and competitive intelligence) and provide critical evaluations on the clinical operations.
• Build and lead a team of executives for each of the current hospitals in their zone.
• Lead and coordinate internal and external PV audits and inspections.
• Monitor PV system performance and compliance of partners and distributors
• Act as the responsible contact person in the region, internally and externally, for safety - related aspects and PV.
• Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
• Perform other duties as assigned.
• Meeting the clinical readiness of the site/hospitals
• Meeting regulatory requirements as per GLP/hospital ethics guidelines
• Training of the hospital personals (nurses/ other staf f ) on CAR-T products infusion and management
• Positive satisfaction ratings f rom the clinical/hospital teams).
• Leadership qualities in terms of training and motivating direct reportees
• Stakeholder management internally and externally.
• Domain expertise in Cell Therapies, CAR-T, biologics manufacturing is plus.
• Excellent verbal, written, presentation and interpersonal skills.
• Strong analytical and problem-solving skills.
• Proactive, creative, self -motivated, flexible to work in a small company environment and assume a wide variety of tasks.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Ability to manage multiple projects simultaneously.
• Strong attention to detail.
• Ability to work under pressure.