Senior Director Immunology Strategy and Development
vor 3 Wochen
At CSL Behring, we are committed to saving and improving lives by delivering high-quality medicines that treat people with rare and serious diseases.
Job SummaryWe are seeking an experienced Senior Director to join our team in King of Prussia PA, Bern Switzerland or Zurich Switzerland office. As a key member of our Clinical Research and Development team, you will be responsible for providing strategic and clinical leadership to assigned clinical development programs or individual clinical trials from conceptualization through execution.
About the Role- Create clinical development strategies and delivery plans for investigational and marketed products according to the Therapeutic Area- and global Product strategy.
- Author and main contributor to program and study level documents and educational materials for internal and external trainings according to the scientific/medical strategy; main contributor to the CSR and external presentations and manuscripts, supports appropriate scientific and medical interpretation and communication of clinical trial data; authoring study reports and as SME makes substantial contributions to regulatory dossiers, including briefing documents, submission summary documents (SCE, SCS, CO) and responses to Health Authority questions.
- Identify potential challenges, risks and roadblocks associated with the global clinical development strategy and its execution and acts as a leader and subject matter expert in developing solutions to address these, working with partners and matrix team members.
- Serve as a senior medical representative on the clinical development and product strategy teams as assigned; responsible for presenting study data and program strategic plans to internal governance committees for endorsement and main program milestones; support product label development, provides product/program specific input for target product profile(s),
- Responsible for delivery of clinical programs by providing scientific and clinical development expertise for the safe, efficient, and 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 excellent patient safety and data integrity, including ongoing review of blinded data.
- MD (Medical Doctor degree) or international equivalent from a recognized school of medicine plus accredited residency.
- 2+ years minimum experience as a physician in patient care.
- 5 + years pharmaceutical / biotechnology industry experience, of which 2 years include accountability for Phase 2b/3 clinical development programs. Relevant academic research experience will also be considered.
- Knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of regulations, ICH/GCP, adverse event management.
- Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
We offer a highly competitive compensation package, including a base salary of $225,000 - $275,000 per year, depending on experience, plus benefits such as medical, dental, vision, 401K, and paid time off.
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Opfikon, Zürich, Schweiz CSL VollzeitCSL Behring is a global biotechnology leader driven by a commitment to saving and improving lives. Millions of people worldwide live with rare and serious medical conditions, and CSL is dedicated to delivering high-quality medicines that enhance their lives.As a Senior Director in the Immunology Therapeutic Area, you will play a critical role in developing...
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