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Senior Director, Immunology TA

1 month ago

King of Prussia PA United States CSL Behring Full time
Job Description

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Senior Director of Clinical Research and Development? This is a hybrid role in our King of Prussia PA, Bern Switzerland or Zurich Switzerland office. You will report to the Global Clinical Lead Immunology, Immunology TA .

The Opportunity

This is an essential matrix leadership role, providing strategic and clinical and medical leadership to assigned clinical development program(s) or individual clinical trial(s) from conceptualization through to execution.  As a medical subject matter expert in the Immunology therapeutic area, functions as the clinical representative on Clinical Development Team(s) (CDT) or on Project Strategic Teams(s) (PST), as assigned. 

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.
  • You will 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.
  • You will be 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.

Your experience

  • 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.

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off

#LI-Hybrid

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.

Do work that matters at CSL Behring