Senior Director Clinical Development Nephrology

1 week ago


King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time

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 Clinical Development? This is a hybrid role located in our King of Prussia PA or Marburg Germany office. You will report to the Physician Lead.

The Clinical Program Leader is a critical role within Clinical Development and accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment with global responsibility for medical oversight of selected pipeline and products within.

  • Manage the daily operations of the CDT including meeting coordination and documentation and partner management.
  • Develop the Clinical Development Plan (CDP).
  • Ensure that the program is conducted with CSL Behring processes and abiding by GCP and ICH regulations.
This position is accountable for the medial oversight of the assigned program and:

  • Ensure medical standards are met during the program
  • Provide medical oversight and expertise during development of clinical studies
  • Be a medical monitor for assigned clinical trials
  • Be a Clinical Development medical representative on the required Delivery Teams (DT)

You are the "Lead Author" or "Contributing Author" for:

  • Main study documents, including Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).
  • the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs.

Qualifications:

  • MD (Medical Doctor degree) or international equivalent plus accredited residency.
  • Two (4) years minimum experience as a physician in patient care, preferably in the field of Nephrology
  • 5+ years pharmaceutical / biotechnology industry experience, which include accountability for medical oversight/evaluation or clinical development.
  • Industry experience in designated therapeutic area(s).
  • Previous line/matrix management experience and a record of accomplishments in managing people.
  • Experience and success in 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

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL
  • Business Development

    2 weeks ago


    King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Summary of RoleReporting to the Senior Director Global Business Development and Licensing, this role is responsible, on a global basis, for business development and licensing activities for the CSL product portfolio.This includes leading cross-functional, global and regional diligence and deal teams, and negotiating license and distribution agreements...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    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...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Reporting to: Vice President, Commercial Co-Lead Hematology Therapeutic AreaPosition Description SummaryThe Senior Director Hematology, GCD Lead for Patient Blood Management (PBM) is responsible for the development and execution of global commercial strategies for pipeline products across the entire Hematology Therapeutic Area (TA), focusing on strategic...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    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...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Role Overview:The Director of Strategic Pricing is responsible for pricing valuation during the early and late stages of medicine development, accountable for developing launch pricing strategies, and optimizing the launch sequence for pipeline and peri-launch assets. This role will focus on ensuring optimal pricing strategies for the assigned products. The...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Sr. Director, Head of Global Medical Information will oversee the global core functions of Medical Information across all therapeutic areas/products at CSL Behring, medical review of core promotional materials, collaboration with cross-functional teams and harmonization of medical information processes globally. Responsible for the medical information...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Opportunity:Reporting to the Director and Lead Counsel, Global Clinical Legal, as the Counsel, Clinical Vendor Contracts, you will provide practical, timely, and high-quality legal support to the Global Clinical Development function of CSL, with a dedicated focus on Clinical Outsourcing, Chemistry Manufacturing & Controls (CMC), Clinical Trial Supply...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Opportunity:Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the short-term forecasting center of Excellence (CoE) at CSL Behring.In this role, you will build and lead a centralized team of forecasters to drive the 3-year forecasting process at CSL Behring. You will be responsible for timely delivery and...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Executive Director, Patient Experience and Operations is a leader of a large multifunctional team of >40 FTEs and >100 contractors, including field and head office-based roles across the patient journey including patient services, field reimbursement, patient engagement, and business operations teams within forecasting and Learning and Development. This...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Digital Health is a rapidly maturing commercial capability that is accountable for the design, development and delivery of digital health solutions that add value for CSL customers. These solutions may include companion software applications, web applications, enabling of connected devices, and 3rd party partnerships. Success in Digital Health requires deep...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Reporting to the Senior Director of Global Forecasting and Portfolio Analytics, you will lead forecasting programs centered around decision analytics for the CSL Behring portfolio.You will use your experience in decision sciences and analytics, paired with industry insights, to lead process improvements and enhance decision analytics capabilities,...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    Reporting into the SVP Global Medical Affairs, Behring, The Director, Therapeutic Area (TA) Program Management is responsible for a team of project managers who work with other medical functions to ensure timely execution of business operations including those relating to planning, budget, and execution.You will work closely with IT, Global Business...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Opportunity:In this role you will be responsible for driving the development and execution of forecasting models and analytics strategies to support business development initiatives, commercial revenue forecasts, and representing the function within the commercial due diligence team. You will own the development and management of commercial revenue...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Opportunity:Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting function for CSL Behring,In this role, you will drive decision-making across all BD&L due diligence efforts via commercial revenue forecasting for both pre- and full-fledged due diligence workstreams and represent I&A forecasting...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Opportunity:The Senior Manager Patient Services operates as a therapeutic area program lead overseeing the delivery of US patient services across multiple vendors within that franchise. Responsibility includes operational development, maintenance, and execution of CSL Behring patient services programs as the dedicated lead for patient services for one of...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    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.Could you be our next PB Clinical Trial Manager? You will be hybrid in our King of Prussia office. You...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The Senior Manager, Competitive Intelligence is responsible for all Competitive Intelligence (CI) support across entire CSLB inline portfolio for the affiliates across US and INT regions.You will be critical for investigating and answering key business questions for the affiliate influencing commercial decisions and following global guidelines and best...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    As the Director, Asset Innovation Evaluation you will be responsible for development of Commercial opportunity assessments that inform prioritization and decision-making regarding investment in internal and external asset-level innovation.This role works closely with the Global Commercial Development Therapy Area (TA) Teams, R&D, Global Insights, and...


  • King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    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...