Roles and Responsibilities
- 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.
Key Performance Indicators
- Meeting the clinical readiness of the site/hospitals
- Meeting regulatory requirements as per GLP/hospital ethics guidelines
- Training of the hospital personals (nurses/ other staff) on CAR-T products infusion and management
- Positive satisfaction ratings from the clinical/hospital teams).
- Leadership qualities in terms of training and motivating direct reportees
- Stakeholder management internally and externally.
Qualifications and Educational Requirement
- 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
Desired Qualities
- 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.