Immuneel Therapeutics Pvt. Ltd. is a pioneering start-up at the forefront of cell therapy and personalized immunotherapy in India. Focused on bringing cutting-edge cell and gene therapies to patients, Immuneel’s innovative approach is helping to redefine cancer treatment. The company is proud to be part of India’s growing biotechnology sector, with a global outlook and a strong commitment to patient care.
Immuneel is dedicated to connecting within, collaborating globally, and creating solutions that can change the future of cancer treatment. The organization fosters a dynamic work environment where diversity, innovation, and work-life balance are highly valued. Their team consists of passionate professionals who work tirelessly to achieve the best outcomes for patients while driving progress in the field of medical research.
Responsibilities in the Specialist – Clinical Development & Operations Role
As a Clinical Development & Operations Analyst at Immuneel Therapeutics, you will be playing a key role in supporting and coordinating clinical trials to ensure the integrity and success of research projects. Your key responsibilities will include:
- Clinical Trial Management: Developing materials and tools for clinical trials, such as protocols, visit schedules, informed consent forms, and checklists.
- Study Feasibility & Coordination: Assisting in study feasibility assessments and ensuring that the necessary supplies for trials are available and in good condition.
- Stakeholder Engagement: Managing communication packages for stakeholders, ensuring the smooth running of clinical trials, and coordinating with CROs to ensure adherence to protocols.
- Data Collection & Analysis: Collecting, coding, and analyzing data obtained from clinical research while managing research budgets and ensuring the accuracy of cost tracking.
- Pharmacovigilance & Safety: Ensuring the proper documentation and reporting of non-serious and serious adverse events as part of the pharmacovigilance efforts.
- Administrative Support: Organizing study files, maintaining regulatory binders, and contributing to scientific and medical liaison communications.
Your role will also involve promoting ethical research practices and assisting in regulatory submissions, ensuring compliance with quality, regulatory, and ethical standards.
Qualifications Required
To be considered for the Specialist – Clinical Development & Operations position at Immuneel Therapeutics, candidates should meet the following qualifications:
- Educational Background: A postgraduate degree in medicine, life sciences, health sciences, or an equivalent qualification. A degree in management is desirable.
- Experience: Minimum of 6 years of relevant experience in clinical development and clinical trial management, with at least 2-3 years of experience in the industry. Oncology trial experience is mandatory.
- Specialized Knowledge: Knowledge of clinical research & development, project management, risk management, and contingency planning. Experience in oncology research trials is highly desirable.
- Certifications: GCP (Good Clinical Practice) trained.
Skills Required
To succeed in this role, the following technical and soft skills are necessary:
- Technical Competencies:
- Clinical Development & Research Operations
- Pharmacovigilance
- Scientific Writing
- Project Management & Data Management
- Soft Skills:
- Teamwork: Ability to work effectively as part of a collaborative team.
- Communication: Clear and concise communication with stakeholders, team members, and management.
- Problem-solving & Judgment: Capable of making well-informed decisions and resolving issues as they arise.
- Resourcefulness & Patient Orientation: Ensuring that patient care remains at the forefront of all clinical operations.
