Director, Clinical and Translational Development

Position Overview

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POSITION SUMMARY: We are seeking an experienced and dynamic leader for the role of Director, Clinical and Translational Development within our Therapeutics & Innovations Business Unit. Reporting directly to the head of the Therapeutics & Innovations division, this role will be responsible for leading, planning, and overseeing clinical trials, pre-clinical studies, and associated activities to advance our therapeutic candidates from discovery through clinical development.

The ideal candidate has significant experience managing clinical and pre-clinical research projects, deep knowledge of regulatory pathways, and a proven track record of successfully advancing therapeutics through various stages of development.

Primary Responsibilities

• Lead the planning, execution, and oversight of clinical trials and pre-clinical research programs, ensuring alignment with strategic objectives and regulatory requirements
• Design and oversee implementation of clinical trial protocols, ensuring scientific rigor, regulatory compliance, and ethical standards
• Collaborate closely with biostatisticians to implement appropriate clinical trial designs, data analysis methodologies, and ensure robust statistical approaches
• Lead the development of critical clinical documents, including clinical development plans, target patient profiles, and site training materials
• Develop and deliver presentations and reports for internal and external stakeholders, including advisory boards, steering committees, and training materials
• Serve as the primary point of contact for clinical development programs, providing regular updates to senior leadership and external partners
• Collaborate with cross-functional teams including R&D, Regulatory, Medical Affairs, Quality Assurance, and external CROs to ensure seamless coordination and execution of development programs
• Develop and implement robust clinical and pre-clinical development strategies and study designs
• Oversee clinical trial management, including site selection, patient enrollment, monitoring, data analysis, and reporting
• Ensure compliance with applicable regulatory standards (e.g., FDA, EMA) and internal SOPs, and proactively manage risks associated with clinical and pre-clinical activities
• Lead interactions with regulatory agencies, preparing and reviewing submissions such as INDs, CTAs, and other regulatory filings
• Manage budgets, timelines, and resources effectively to achieve development milestones
• Mentor and manage a high-performing team, promoting a collaborative, innovative, and results-driven culture.

Qualifications

• Advanced degree (Ph.D., MD, PharmD, or equivalent) in life sciences, biology, pharmacology, or a related discipline
• Minimum of 10 years of relevant industry experience in clinical and/or pre-clinical drug development
• Proven leadership in managing clinical trials and pre-clinical studies within a biotechnology or pharmaceutical company
• In-depth understanding of clinical trial design, execution, regulatory requirements, and compliance standards
• Experience interacting directly with regulatory bodies (FDA, EMA) and preparation of regulatory documentation
• Excellent organizational, communication, interpersonal, and leadership skills
• Strong analytical and problem-solving abilities with keen attention to detail
• Proven ability to manage complex projects, budgets, and timelines effectively

Preferred Qualifications

• Experience in oncology, immuno-oncology, personalized cancer vaccines, or related precision medicine therapeutic areas
• Familiarity with biomarker-driven clinical trials and personalized therapeutic approaches
• Experience in leading cross-functional teams, including external academic collaborations and contract research organizations (CROs)

Note: The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years of experience.