Executive Director, Head of Clinical Science, Medical Writing & Decision Support
Executive Director, Head of Clinical Science, Medical Writing & Decision Support
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1 Vacancy
Job Description
CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 high-quality clinical development documents and oversight of clinical study delivery 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. Serve as the decision support lead for the SVP Portfolio Development (PD) and ensure excellence throughout the Portfolio Development organization.
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
Oversight of and collaboration with partnering functions e.g. Research GRA & Safety POE TES CROs and Medical Writing Vendors
Effecting extensive and collaborative dialogue with TA co-leads to optimize project strategy
Working with Head Clinical Operations to ensure appropriate resourcing to support TA activities and to ensure project planning and execution is aligned with TA Priorities
Maintaining effective oversight of quality in conjunction with appropriate Quality functions
External-scientific
Enhancing the reputation of the Company through a culture of scientific integration of the department with academia and other partners through visible publication record KOL Interactions presence at scientific conferences membership of consortia and similar medico-scientific groups builds networks with scientific experts
Ensures that the patient and physician voice is at the forefront in TA strategy development
Building a culture of risk taking innovation and peer review across the clinical function
Providing clinical scientific leadership throughout CSL
Providing support and insight into business development opportunitiesas required
Qualifications & Experience Requirements
Experience across all phases of development FIH POC late-stage development and life cycle 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
10yrs of pharma experience in clinical development
Strong personal leadership skills
High level of self-awareness and the awareness of personal impact
Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
Succinct and clear communication style
Extensive experience of leading teams and/or line managing a group(s)
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL
Do work that matters at CSL Behring!
Required Experience:
Director
Employment Type
Full-Time
