The Opportunity
Reporting to a Global Clinical Lead, you will play a multifunctional, clinical individual contributor role in the Immunology and Transplant Therapeutic Area (TA). You will be responsible for translation of the TA and global product strategy into clinical development strategy and for delivery of clinical studies accordingly. You will author regulatory dossiers, including briefing documents, submission summary documents (SCE, SCS, CO) and responses to questions.
As a matrix leader, you will provide strategic and tactical clinical and medical leadership to assigned clinical development program(s) or individual clinical trial(s) from conceptualization through execution. As medical subject matter expert in the assigned therapeutic area, you will function as the clinical representative on Clinical Development Team(s) (CDT) and on Project Strategic Teams(s) (PST) as assigned.
The Role
Create clinical development strategies and delivery plans for investigational or marketed products according to the strategy of Therapeutic Area and global Product Strategy Team.
Author program and study level documents and educational materials for internal and external trainings according to the scientific/medical strategy; contribute to the CSR and external presentations and manuscripts, supporting appropriate scientific and medical interpretation and communication of clinical trial data; author study reports and as SME, contribute to regulatory dossiers , including briefing documents, submission summary documents (SCE, SCS, CO) and responses to questions
Identify potential challenges, risks and roadblocks associated with the global clinical development strategy or its execution and act as a leader and subject matter expert in developing solutions to address these, working cross-functionally with important partners and matrix team members
Be a senior medical representative on the cross-functional therapeutic area clinical development and product strategy teams as assigned; present study data and program strategic plans to internal governance committees for endorsement and main program milestones; support product label development and maintenance, provide product/program specific input for target product profile(s)
Deliver clinical programs by providing scientific and clinical development expertise for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs
Accountable for global medical oversight of selected product(s) within the assigned therapeutic area(s) and responsible for defining and implementing medical monitoring and oversight strategy for individual clinical studies to ensure exceptional patient safety and data integrity, including ongoing review of blinded data
Interface with key internal and external stakeholders; represent CSL as the scientific subject matter expert at external meetings including those with Regulators, Investigators, Steering Committees, Advisory Groups
Oversee the activities of Clinical Scientists or other Clinical Directors in the execution of clinical studies if assigned and contribute to diverse working groups to support continuous process improvement
Assist the TA Global Clinical Lead in ensuring that appropriate personnel is informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
Support BD&L activities, (potentially across therapeutic areas based on scientific background and drug development expertise) by providing medical/scientific evaluation of potential new products and competitor assessments and makes recommendations according to the strategic fit in the respective TA
Maintain awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
Your skills and experience
MD (Medical Doctor degree) or international equivalent from a recognized school of medicine plus accredited residency
PhD or board certification in therapeutic areas of interest for CSL including Immunology and Transplant or specialty training in Pharmaceutical Medicine are desirable
Two (2) years minimum experience as a physician in patient care.
5 + years pharmaceutical / biotechnology industry experience, which includes accountability for medical oversight/evaluation or Phase 2b/3 clinical development experience. Relevant academic research experience will also be considered.
Extensive knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of global and regional regulations, ICH/GCP, adverse event management.
Demonstrated experience with global regulatory submissions (e.g., NDA, BLA, MAA) preferred.
Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
Track record of medical credibility and excellence - achievement in pharmaceutical development, ability to coordinate and execute clinical development.
Demonstrated record of scientific scholarship and achievement, including successful authorship of peer-reviewed scientific publications.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
