Executive Director, Head of Clinical Science, Medical Writing and Decision Support

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Executive Director, Head of Clinical Science, Medical Writing and Decision Support

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CSLCSL''s RandD 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.Responsibilities

Oversee the quality and delivery of high-quality clinical development documents and clinical study delivery across the portfolio in collaboration with strategic CRO partners.Manage recruitment, staffing and development of the clinical scientists and medical writing specialists in the group.Serve as the decision support lead for the SVP Portfolio Development (PD) and ensure excellence throughout the Portfolio Development organization.Provide leadership for the recruiting, staffing, and development of clinical scientists and medical writing specialists to maintain a cutting-edge level of medical scientific expertise and drug development approaches.Oversee the preparation of clinical development plans, protocols, study reports, common technical document modules and publications for regulatory submissions and publications in academic journals.Oversee regulatory submissions and meetings and ensure stage-gate and benefit–risk evaluations and assessments are integrated into decision making.Support presentations at scientific and technical review committees and implement clinical recommendations from advisory and governance committees.Collaborate with partnering functions (e.g., Research, GRA and Safety, POE, TES, CROs and Medical Writing Vendors) to ensure alignment and delivery.Engage with TA co-leads to optimize project strategy and ensure appropriate resourcing to support TA activities.Maintain effective oversight of quality in collaboration with appropriate Quality functions.Enhance CSL’s external scientific reputation through publication activity, KOL interactions, conference presence, and participation in consortia and medico-scientific groups.Ensure patient and physician voices are at the forefront in TA strategy development.Foster a culture of risk-taking, innovation, and peer review across the clinical function and provide clinical scientific leadership throughout CSL.Provide support and insight into business development opportunities as required.Qualifications and Experience

Experience across all phases of development, including FIH, POC, late-stage development and lifecycle management.Strong track record of oversight of successful drug development programs.Experience across a wide range of regulatory interactions (e.g., filings, Ad Coms, etc.).10+ years of pharma experience in clinical development.Strong personal leadership skills and high self-awareness, with the ability to influence from the team level to senior management.Excellent communication skills and the ability to lead and develop teams.Extensive experience in leading teams and/or line management of groups.Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We focus on serving patients’ needs by using the latest technologies to discover, develop and deliver innovative therapies in 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 address unmet medical needs.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 therapies to people in more than 100 countries.We want CSL to reflect the world around us. Inclusion and Belonging are at the core of our mission. By celebrating our differences and fostering curiosity and empathy, we connect with patients and donors, sustain a diverse workforce, and move our company and industry forward.Do work that matters at CSL Behring!Job Attributes

Seniority level: Not ApplicableEmployment type: Full-timeJob function: Business Development and SalesLocation: Maidenhead, England, United KingdomPosted: 2 days ago

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