Executive Director, Global Clinical Lead – Hematology

The Opportunity

Reporting the Vice President, Head of Clinical Development , you will play an important leadership role in the Clinical Development Group, providing strategic and tactical medical guidance for the clinical development project-work of a team of Physician direct reports and support their professional development. Also, as a subject matter expert in Hematology, you will have direct project responsibilities as assigned. You will also function as the clinical representative on the Therapeutic Area Leadership Team (TALT) for Hematology.

The Role

• Provide strategic and tactical medical guidance for clinical development activities for a team of Physicians
• Work with other Physician and Scientist managers and Head of Clinical Development to ensure resourcing across the assigned portfolio.
• Manage team of clinical development physicians, act as a mentor, guides clinical development activities in all phases of drug development in general and in specific areas of therapeutic area knowledge
  • Contribute to global clinical development strategy for all projects in the Hematology TA
  • Ensure that high quality clinical and scientific content is provided into regulatory submissions,  ensure defense and negotiation with regulatory agencies
  • Lead/support preparations for stage-gate evaluations and benefit–risk assessments
• Oversee and support clinical development activities/tasks of direct reports and work in a matrix with the TALT, PST/Global Project Leaders (GPLs) and Clinical Development Team (CDT) leaders to ensure clinical translation of the TA strategy and its execution according to internal and external quality standards. Will take on medical lead responsibilities for projects (as assigned).
• Ensure that the patient and physician voice is at the forefront in strategy development
• Build networks with external experts
• Drive excellence in clinical development execution
• Provide input into Business Development strategy and due diligence for TA & identify and evaluate NPOs
• Partner with TA core, extended core and functional partners to ensure scientific & medically robust Clinical Development & Medical Affairs activities
• Enhance the reputation of CSL Behring through thought leadership, KOL interactions in fundamental issues affecting the TA
• Represent CSL and the TA externally with KOLs, Health Technology and external authorities at important forums
• Responsible for presentation at internal governance bodies (STRC, TPRC, etc.)
• Will represent the clinical function on the Hematology TALT, responsible for input into TALT strategy, overseeing the quality of clinical plans in the Hematology therapeutic area.

Your skills and experience

• Minimum of a Medical Doctor (MD or equivalent) Degree is required.
• Board certification (or non-US equivalent) in Hematology with relevant sub-specialty in either hemoglobin-associated disease or coagulation disorders or gene therapy is preferred. In lieu of Board Certification, extensive experience in hematology clinical research & development is required.
• Minimum of 8 years of experience required in pharmaceutical/biotech or related industry or a combination of industry and academic experience along with experience working with industry sponsors
• Clinical development experience leading a therapeutic area or complex clinical program(s) (biologics and small molecules) with a working knowledge of pharmaceutical and regulatory development processes is essential
• Experience working with health authorities (HAs) and designing programs that meet the needs of HAs, the commercial function and payors

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.

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.

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