Senior Director, Immunology TA
Company: CSL Behring
Location: King Of Prussia
Posted on: April 22, 2024
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
OpportunityThis 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 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!
Keywords: CSL Behring, Cherry Hill , Senior Director, Immunology TA, Executive , King Of Prussia, New Jersey
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