Immuneel Therapeutics
Website:
immuneel.com
Job details:
About Immuneel
Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com
We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.
Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:
- Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
- Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
- Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
- Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.
Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.
If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.
Interested to be a part of the next revolution in cancer treatment? Send your resume to careers@immuneel.com
1. Role Title:
Clinical Development & Operations
2. Department/Function:
Clinical Development & Medical Affairs
3. Reporting Structure:
- Reports to: Clinical Development & Medical Affairs
- Direct Reports: Clinical Development & Operations Team
4. Role Summary:
The Clinical development and operations role will lead the clinical development l strategy for the organization’s portfolio, ensuring alignment with business goals and regulatory standards. This role is responsible for overseeing clinical trials, regulatory submissions, and stakeholder engagement, as well as providing scientific leadership across various stages of clinical development. The individual will collaborate closely with internal and external stakeholders to drive the success of clinical programs, ensure patient safety, and promote the organization’s vision for innovative healthcare solutions.
5. Key Responsibilities:
Clinical Development:
- Lead the design, execution, and management of clinical development programs from early-phase to late-stage trials, ensuring alignment with the organization’s strategic goals.
- Develop and execute clinical development plans for new therapies and products, including protocol design, patient recruitment strategies, and study management.
- Work with cross-functional teams (R&D, regulatory, commercial) to integrate clinical insights into overall development strategies.
- Ensure clinical trials meet regulatory standards (FDA, EMA, ICH-GCP) and are conducted efficiently within budget and timelines.
- Provide medical and scientific oversight for clinical trials, ensuring patient safety and scientific integrity.
- Lead the development of medical strategies and communication plans to support product approvals and commercial launches.
- Engage with key opinion leaders (KOLs), investigators, regulatory agencies, and external partners to build relationships and maintain scientific excellence.
- Develop clinical presentations, abstracts, and publications to showcase clinical outcomes at scientific conferences and in peer-reviewed journals.
Clinical Operations Management:
- Oversee multicentric clinical trial operations in India and for global clinical trials for pipeline products, including protocol development, site selection, patient recruitment, and data analysis.
- Manage CROs, investigators, third-party laboratories, and other stakeholders to ensure adherence to timelines and protocols.
- Implement risk management strategies to address trial challenges and maintain successful trial execution.
- Monitor clinical performance through audits, reviews, and feedback, ensuring corrective actions are taken as necessary.
- Ensure GxP throughout the clinical trial operations
Regulatory Compliance:
- Collaborate with regulatory affairs to support clinical trial applications (IND, CTA) and ensure compliance with Indian and global regulatory requirements.
- Provide input on regulatory submissions, including clinical study reports, safety reports, and product labelling.
- Monitor patient safety throughout clinical trials, overseeing adverse event reporting and safety management procedures.
Stakeholder Engagement:
- Serve as the primary point of contact for internal and external stakeholders on clinical and medical matters, providing updates to senior leadership, regulatory agencies, and key partners.
- Develop and maintain strong relationships with KOLs, investigators, CROs, and healthcare professionals in relevant therapeutic areas.
- Represent the organization at national and international scientific meetings, presenting clinical outcomes and engaging with the scientific community.
Team Leadership and Development:
- Lead and mentor the clinical development and operations team, fostering a culture of scientific excellence, collaboration, and continuous improvement.
- Ensure team members are trained in best practices for clinical development, compliance, and regulatory requirements.
- Promote innovation within the team, identifying opportunities for process improvements and implementing best practices in clinical and medical operations.
Budget and Resource Management:
- Manage clinical and medical budgets, ensuring efficient allocation of resources and cost-effective trial execution.
- Collaborate with finance and operations teams to forecast clinical development costs and allocate resources accordingly.
6. Primary Objectives:
- Clinical Development Strategy
- Clinical Operations Management
- Regulatory Compliance Safety
- Stakeholder Engagement
- Team Leadership and Development
- Budget and Resource Management
7. Competencies Required:
- Technical Competencies:
- Strategic leadership and vision with the ability to drive clinical and medical strategies.
- Exceptional communication and stakeholder management skills.
- Expertise in clinical trial design, regulatory compliance, and safety monitoring.
- Ability to manage multiple projects simultaneously and work in a fast-paced, dynamic environment.
- Strong analytical skills, with the ability to interpret and present complex clinical data.
- Experience in clinical trials, teaching, training, public speaking, presenting papers & publications
- High motivation to create impact, Ability to drive results.
- Understanding of clinical trial applications
- Strategic thinking and problem-solving
8. Qualifications:
- MD or a related medical discipline.
- Clinician – preferably Pathologist/ Pharmacologist/ haemato-oncologist
- 15+ years of clinical and medical experience in the biotechnology, pharmaceutical, or healthcare industry.
- Proven track record of leading clinical development programs from Phase I to Phase III and beyond.
- Strong knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and healthcare industry standards.
9. Working Conditions:
- Role Type: Full Time and Onsite
- Work Hours: 9:00 AM to 6:00 PM for the General Shift
- Travel Requirements: Yes
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099
Click on Apply to know more.
