Job Title: Vice President, Clinical Development

Location: Indiana, US

Company Overview:
A pioneering clinical-stage biotechnology company dedicated to developing innovative immunotherapies for the treatment of various cancers. Their cutting-edge research focuses on harnessing the power of the immune system to fight against malignant tumors. With a strong pipeline of promising drug candidates and a talented team of scientists and clinicians, they are committed to transforming the landscape of cancer treatment.

Position Summary:
The Vice President, Clinical Development will play a pivotal role in leading the company's clinical development strategy and execution within Hematological Malignancies. This individual will oversee all aspects of clinical trials, from study design and implementation to data analysis and regulatory submissions. The VP, Clinical Development will work closely with cross-functional teams, including research, regulatory affairs, and commercial partners, to ensure the successful advancement of the Hematological Malignancy pipeline.

Key Responsibilities:

1. Develop and execute comprehensive clinical development strategy for the company's oncology pipeline, ensuring alignment with scientific, regulatory, and commercial objectives.

2. Lead the design, initiation, and management of clinical trials, including phase I, II, and III studies, across multiple oncology indications. Ensure adherence to GCP guidelines, regulatory requirements, and ethical standards.

3. Oversee the selection and management of clinical research organizations (CROs), investigator sites, and other clinical trial vendors. Monitor study progress, data quality, and patient safety.

4. Collaborate with biostatisticians and data management teams to analyze clinical trial data, interpret results, and prepare scientific reports and regulatory submissions.

5. Serve as the primary liaison with regulatory agencies, such as the FDA, for clinical trial-related matters, including IND/NDA submissions, protocol reviews, and regulatory inspections.

6. Foster effective communication and collaboration with internal teams, including research, regulatory affairs, manufacturing, and commercial, to ensure alignment and seamless execution of clinical development programs.

7. Provide medical oversight for clinical studies, ensuring patient safety and adherence to ethical and regulatory standards.

8. Build, manage, and mentor a high-performing clinical development team, fostering a culture of excellence, innovation, and continuous improvement.

Qualifications:

1. Advanced degree (Ph.D., M.D., or equivalent) in a relevant scientific discipline, such as oncology, immunology, or pharmacology.

2. Minimum of 10 years of experience in clinical development, with a strong focus on oncology drug development and immunotherapy.

3. Proven track record of successfully leading clinical trials from early-stage to late-stage development, including regulatory submissions and interactions.

4. In-depth knowledge of FDA and ICH guidelines, GCP regulations, and industry best practices in clinical trial design and execution.

5. Excellent leadership, project management, and problem-solving skills, with the ability to manage multiple priorities and cross-functional teams.

6. Strong analytical and data interpretation skills, with the ability to translate complex scientific data into actionable insights.

7. Excellent communication and presentation skills, with the ability to effectively communicate with internal stakeholders, external partners, and regulatory agencies.

8. Collaborative and team-oriented approach, with the ability to build and maintain strong relationships with cross-functional teams and external partners.

This role offers a unique opportunity to be at the forefront of hematological malignancy drug development and make a significant impact on the lives of cancer patients. The successful candidate will thrive in a fast-paced, innovative environment and contribute to the company's mission of developing transformative immunotherapies.

📩rsharma@i-pharmconsulting.com

📞(704) 247 5242