Role: Clinical Development Lead- Immuno-Oncology
Company: A Global Biotechnology company that focuses on immuno-oncology therapeutics for patients.
Location: 3-4 days per month in the office in Greater Charleroi area.
A dynamic and strategic leader is sought for the role of Clinical Development Lead in Immuno-Oncology. The ideal candidate will have a strong track record in immuno-oncology drug development, the ability to drive strategy, and a hands-on approach to solving challenges in clinical trial execution. This role will oversee a key clinical development program, working closely with cross-functional leaders to ensure the successful design, execution, and interpretation of clinical trials.
The position reports to the SVP of Clinical Development and will manage clinical scientists, study physicians, and CRO staff as needed. The Clinical Development Lead in Immuno-Oncology will lead the clinical development team and play a pivotal role in developing and implementing clinical strategies.
MAIN RESPONSIBILITIES
* Strategic Leadership: Develop and oversee the clinical development strategy for assigned programs, including identifying and prioritizing indications and therapeutic combinations, ensuring alignment with corporate goals. Collaborate with project heads and functional leaders to create a roadmap that advances the program from early development to regulatory submission.
* Clinical Development Plan (CDP): Lead the development and ongoing refinement of a comprehensive CDP, ensuring a proactive, data-driven approach that aligns with regulatory and commercial objectives while anticipating risks and challenges.
* Protocol Development & Study Design: Drive the execution of clinical study protocols that align with strategic objectives. Collaborate with biostatistics, clinical operations, data management, and regulatory teams to ensure protocols are executable, efficient, and scientifically rigorous.
* Data Review & Interpretation: Engage in the review, analysis, and interpretation of emerging clinical data to provide clear insights into program efficacy, safety, and patient outcomes. Ensure data-driven decisions are made promptly and communicated effectively to stakeholders.
* Medical Monitoring & Oversight: Serve as the Clinical Development Lead and/or Medical Monitor, overseeing patient safety, study integrity, and data quality. Identify and mitigate risks proactively during study conduct. Work closely with medical monitors to maintain continuous vigilance over investigational agents’ safety profiles.
* Cross-functional Collaboration: Work closely with regulatory affairs, translational medicine, clinical pharmacology, and clinical operations to ensure alignment on clinical trial design, execution, and regulatory submissions. Partner with commercial and market access teams to ensure clinical development programs align with market needs and health authority requirements.
* Regulatory & Medical Affairs Support: Lead or contribute to clinical sections of regulatory submissions, including INDs, investigator brochures, clinical study reports, and other key documents. Stay informed about evolving regulatory expectations and trends to guide program strategy and execution.
* Team & Project Leadership: Inspire and lead cross-functional clinical development teams to ensure seamless program execution. Foster clear communication and decision-making across departments to maintain alignment with overall program strategy.
* Mentorship & Team Development: Support and mentor direct reports and team members by providing regular feedback, setting clear goals, and offering professional development opportunities. Build a high-performing team capable of executing complex clinical programs efficiently.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
* Medical Degree with post-graduate training and patient care experience in oncology, immuno-oncology, or a related therapeutic area.
* 5+ years of oncology drug development experience in the pharmaceutical or biotech industry, with a focus on immuno-oncology therapeutics.
* Proven experience in managing and mentoring clinical development teams, fostering ownership and accountability within clinical programs.
* Expertise in designing, conducting, and interpreting clinical trials from early-stage development through regulatory submission.
* Strong understanding of clinical trial design, data review processes, and cross-functional collaboration to optimize trial execution.
* Experience working with regulatory authorities and managing IND submissions and related global regulatory documentation (e.g., US FDA and EU EMA).
* Excellent communication and leadership skills, with the ability to manage and influence across all organizational levels.
* Fluency in English (both written and oral) with the ability to travel (~20%).
OFFER
* A stimulating role within an innovative biotech company.
* The opportunity to work in a science-driven, dynamic, and professional environment.
* A challenging scientific and business growth opportunity where expertise and skills will be valued.
* An employment contract with a competitive salary package aligned with the position’s responsibilities and experience level.