Global Clinical Lead- Hematology

@ CSL

Global Clinical Lead- Hematology

King Of Prussia, PA
Posted 1 week ago

About the job

The company specializes in pharmaceutical development with focus on oncology. The role is a senior leadership position responsible for clinical strategies, team management, and external collaborations to ensure successful hematology programs and regulatory success.

Requirements

  • Clinical development leadership
  • Therapeutic area expertise
  • Experience with pharma regulation
  • Leadership and team management
  • External stakeholder engagement

Qualifications

  • MD or equivalent, subspecialty preferred
  • 8-10 years industry experience
  • Proven leadership skills
  • Strong collaboration skills
  • Experience with health authorities

Full job description

Reporting to the Head, Global Clinical Development the Global Clinical Lead (GCL) will act in a key leadership role in the Clinical Development (CD) group;

  • Providing strategic and tactical Medical & Scientific leadership and guidance for clinical development activities for 5-8 Global Clinical Program Leaders (GCPL)

  • Serving as the CD representative on the Therapeutic Area Leadership team (TALT) for CVR TA

  • May act as any of the following roles in clinical development: GCPL, Early Clinical Development Lead, Business Development (BD) Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead as appropriate for projects as assigned per business need

Main Responsibilities and Accountabilities:

GCL Line Manager responsibilities include:

  • Providing strategic and tactical medical leadership and guidance for clinical development activities in for 5-8 GCPLs
  • Works with other GCLs and head of clinical to ensure adequate resourcing across the portfolio
  • Manages team of clinical drug developers, acts as a mentor to physician group in guide clinical development expertise in general and in specific areas of therapeutic knowledge

GCL TALT CD Representative responsibilities include:

  • Defining the global clinical development strategy for all projects in TA
  • Contributing to BD strategy & due diligence for TA & identifies and evaluates NPOs
  • Ensuring high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agencies
  • Preparing for stage-gate evaluations and benefit risk evaluations and assessments
  • Overseeing and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global Project Leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal Project strategy

GCL Other Responsibilities include:

  • Be an active member of the Clinical Development Leadership Team, improving the overall quality of the group and its deliverables
  • Ensuring that the patient and physician voice is at the forefront in strategy development
  • Building networks with external experts
  • Driving excellence in clinical development execution
  • Partnering with TA core, extended core & functional partners to ensure scientific & medically robust clinical dev & med affairs activities
  • Enhancing the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA
  • Representing the Co & TA externally with KOL, Health Technology and external authorities at key forums
  • Ensuring effective presentations at Scientific and Technical Review Committee
  • Representing the clinical function on the TALT, responsible for input into TALT strategy, oversee the quality of clinical plans in the CVR TA.

Position Qualifications and Experience Requirements:

  • MD, Board Certified (or non-USA equivalent) with relevant sub-specialty highly preferred- if not Board Certified in relevant Subspecialty, then experience in that TA is a must.
  • Clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is essential

  • A minimum of 8-10 years experience preferred, acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors

  • Outstanding influencing ability & collaboration skills

  • Proven leadership experience

  • Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly demonstrated ability to work across the critical interfaces between Clinical and non-Clinical functions

  • Experience interacting with Health Authorities and designing programs that meet the needs of HA’s, commercial and payers

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