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Clinical Trials Director – Immuno-Oncology

Clinical Trials Director – Immuno-Oncology

beBeeClinicalMadrid, Comunidad de Madrid, España
Hace 7 días
Descripción del trabajo

Overview

We are seeking an experienced Associate Director to lead the design, strategic planning, execution, and oversight of clinical trials in immuno-oncology.

Main Responsibilities

  • Develop and implement clinical trial strategies, ensuring delivery within timelines, budget, and quality standards.
  • Design and oversee the Clinical Development Plan for innovative portfolios, focusing on immuno-oncology.
  • Lead scientific advice interactions with regulatory agencies, ensuring compliance with international regulations.
  • Establish and maintain relationships with Key Opinion Leaders (KOLs) to validate clinical trial plans and evaluate new pipeline opportunities.
  • Prepare and manage clinical trial budgets, overseeing financial activities and vendor performance.
  • Select, contract, and manage CROs and external vendors, guaranteeing performance meets agreed cost, quality, and timeline standards.
  • Identify countries, sites, and investigators for trial execution, optimizing scientific, regulatory, and operational feasibility.
  • Oversee the establishment and coordination of independent committees (IDMC, IRC, etc.), ensuring compliance and documentation for regulatory submissions.
  • Supervise the development and review of essential clinical trial documents (protocols, informed consent forms, amendments) in collaboration with medical and scientific teams.
  • Ensure timely regulatory and ethics approvals for clinical trials and protocol amendments, managing preparation and submission of required documentation.
  • Approve and monitor study monitoring plans and related interventions.
  • Review and approve all study-related materials and operational guides.
  • Oversee site documentation and ensure compliance with local and international regulatory requirements.
  • Organize and lead investigator meetings, ensuring effective communication with investigators and partners throughout the study lifecycle.
  • Supervise site files and conduct regular quality control checks to ensure GCP compliance.
  • Ensure adherence to company SOPs, Good Clinical Practice, and all applicable regulations in all assigned clinical trials.
  • Support Business Unit initiatives including process improvement and ad hoc projects.

Requirements

  • A minimum of 6 years in clinical research, with at least 3 years in a leadership role managing international oncology clinical trials.
  • Strong knowledge of clinical trial regulations, laws, and guidelines, particularly in immuno-oncology.
  • Excellent leadership, communication, and interpersonal skills, with experience in leading cross-functional teams.
  • Ability to analyze complex data, identify trends, and make informed decisions.
  • Strong project management skills, with experience in managing multiple clinical trials simultaneously.
  • Familiarity with CROs, vendors, and external partners, with experience in contracting and managing their performance.
  • Ability to work in a fast-paced environment, prioritizing tasks and meeting deadlines.
  • Strategic thinker, with experience in developing and implementing business strategies.
  • Strong understanding of regulatory affairs, including scientific advice and submissions to regulatory agencies.
  • Familiarity with clinical trial software, systems, and tools, with experience in using them to support clinical trials.

    • About Us

  • We believe in innovation and sustainable development, operating across the entire pharmaceutical value chain.
  • We have over 9,000 professionals in more than 50 countries, with 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries serving 1,150 clients worldwide.
  • We are committed to making a positive impact on human and animal health.
  • We offer a dynamic and collaborative work environment, with opportunities for professional growth and development.
  • We prioritize employee well-being, offering a range of benefits and programs to support our team members' physical, emotional, and mental health.
  • We strive to create a diverse and inclusive workplace, where everyone feels valued, respected, and empowered to contribute their best work.
  • We invest in our employees' education and training, providing opportunities for career advancement and professional certification.
  • We foster a culture of continuous learning, innovation, and creativity, encouraging our team members to share their ideas and insights.
  • We promote work-life balance, offering flexible schedules, remote work options, and paid time off.
  • We prioritize sustainability, reducing our environmental footprint and promoting eco-friendly practices throughout our operations.
  • We are committed to transparency, integrity, and accountability, upholding the highest ethical standards in all our business dealings.
  • We value our partnerships with key opinion leaders, healthcare providers, and industry stakeholders, working together to advance medical knowledge and improve patient outcomes.
  • We are dedicated to advancing medical research, investing in cutting-edge technologies and innovations that drive progress in our field.
  • We strive to make a positive impact on the communities we serve, supporting local initiatives and charitable causes that align with our values and mission.
  • We believe in the power of diversity, equity, and inclusion, promoting a workplace culture that celebrates differences and fosters a sense of belonging among all team members.
  • We prioritize employee safety, providing a secure and healthy work environment that protects our team members from harm.
  • We are committed to fair compensation and benefits, recognizing the value and contributions of our team members and rewarding them accordingly.
  • We invest in our employees' physical and mental well-being, offering access to wellness programs, fitness classes, and mental health resources.
  • We strive to create a workplace culture that is fun, engaging, and fulfilling, with opportunities for socialization, teamwork, and community building.
  • We value our employees' feedback and suggestions, regularly soliciting input and acting on it to drive improvements and innovations.
  • We prioritize open communication, transparency, and honesty, fostering a culture of trust and respect among all team members.
  • We are committed to diversity, equity, and inclusion, promoting a workplace culture that values and celebrates differences.
  • We believe in the importance of mentorship and coaching, providing opportunities for our team members to grow and develop their skills and expertise.
  • We invest in our employees' education and training, providing access to courses, workshops, and conferences that enhance their knowledge and competencies.
  • We strive to create a workplace culture that is supportive, inclusive, and respectful, with opportunities for our team members to thrive and reach their full potential.

    • Join Our Team

    Apply now to become part of our dynamic team and contribute to shaping the future of healthcare!

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    Director • Madrid, Comunidad de Madrid, España