Executive Director, Head of Clinical Science and Medical Writing in Thatcham

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regulatory documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group.

Your responsibilities

• Oversight of Individuals: Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches.
• Ensuring delivery of high-quality clinical development content including: clinical development plans, protocols, study reports, common technical document modules and publications in academic journals.
• Regulatory submissions and meetings.
• Stage-gate and benefit–risk evaluations and assessments.
• Presentations at scientific and technical review committees.
• Implementation of clinical recommendations from all advisory and governance committees.
• Internal interfaces and collaboration: Member of the Clinical Development Leadership Team.
• Managing a team of approximately 50 scientists.
• Oversight of and collaboration with partnering functions (Clinical Operations, Research, GRA & Safety) to assure effective project-related deliveries.
• Participation in and/or leadership of enterprise initiatives.
• Maintaining effective oversight of quality in conjunction with appropriate Quality functions.
• External-scientific: Enhancing CSL's reputation through visible publication records, KOL interactions, presence at scientific conferences, and membership in scientific groups; building networks with scientific experts.
• Ensuring that the patient and health-care provider voice is integrated into CSL’s development mindset.
• Building a culture of risk-taking, innovation and peer review across the clinical function.
• Providing clinical scientific and medical writing leadership throughout CSL.
• Providing support and insight into business development opportunities as required.

Your skills & experience

• Graduate level degree (M.Sc, PhD, MD etc) preferred.
• 10 years+ of pharma experience in clinical development.
• Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management.
• Medical writing experience.
• Strong track record of leadership skills.
• Enhanced organizational awareness and the ability to interact and influence from the team level to senior management.
• Extensive experience of leading teams and/or line managing a group(s).

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.