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Title
Text copied to clipboard!Clinical Research Director
Description
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We are looking for a Clinical Research Director to lead and manage our clinical research programs, ensuring the highest standards of scientific integrity, regulatory compliance, and operational efficiency. This role is critical in shaping the strategic direction of our clinical development efforts and plays a key role in bringing innovative therapies to market.
As the Clinical Research Director, you will be responsible for overseeing the planning, execution, and reporting of clinical trials across various phases. You will collaborate with cross-functional teams including regulatory affairs, medical affairs, biostatistics, data management, and clinical operations to ensure that clinical studies are conducted in accordance with applicable regulations and company policies.
You will provide scientific and strategic leadership in the design of clinical development plans and protocols, ensuring alignment with corporate objectives and regulatory requirements. The ideal candidate will have a strong background in clinical research, excellent leadership skills, and a proven track record of managing complex clinical programs.
Key responsibilities include managing clinical trial budgets and timelines, selecting and overseeing CROs and other vendors, ensuring data quality and integrity, and representing the company in interactions with regulatory agencies and key opinion leaders. You will also be responsible for mentoring and developing clinical research staff, fostering a culture of excellence and continuous improvement.
This position requires a deep understanding of clinical trial methodology, regulatory guidelines (e.g., ICH-GCP, FDA, EMA), and therapeutic area expertise. Strong communication and interpersonal skills are essential, as you will be working closely with internal stakeholders and external partners.
If you are passionate about advancing medical science and have the experience and drive to lead clinical research initiatives, we invite you to apply for this exciting opportunity.
Responsibilities
Text copied to clipboard!- Lead the design and execution of clinical development plans
- Oversee all phases of clinical trials from initiation to completion
- Ensure compliance with regulatory requirements and ethical standards
- Manage clinical trial budgets, timelines, and resources
- Collaborate with cross-functional teams to support clinical programs
- Select and manage CROs and other external vendors
- Provide scientific input into study protocols and regulatory submissions
- Monitor data quality and ensure integrity of clinical trial results
- Represent the company in meetings with regulatory agencies and stakeholders
- Mentor and develop clinical research team members
Requirements
Text copied to clipboard!- Advanced degree in life sciences, medicine, or related field (MD, PhD, PharmD preferred)
- Minimum of 8 years of experience in clinical research
- Proven leadership experience in managing clinical trials
- Strong knowledge of ICH-GCP and global regulatory requirements
- Experience with clinical trial design and protocol development
- Excellent communication and interpersonal skills
- Ability to manage multiple projects and priorities
- Experience working with CROs and external partners
- Strong analytical and problem-solving skills
- Ability to work in a fast-paced, collaborative environment
Potential interview questions
Text copied to clipboard!- Do you have experience leading global clinical trials?
- What therapeutic areas have you worked in?
- How do you ensure compliance with regulatory guidelines?
- Describe your experience with CRO management.
- What is your approach to clinical trial budgeting?
- How do you handle data integrity and quality assurance?
- Have you interacted with regulatory agencies? If so, how?
- What leadership experience do you have in clinical research?
- How do you stay current with industry trends and regulations?
- What motivates you to work in clinical research?
