CSL Limited

Global Clinical Lead- Hematology

CSL Limited$160K — $190K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • MD, Board Certified (or equivalent), preferably in relevant subspecialty
  • 8-10 years of clinical development experience in industry or academia
  • Proven leadership skills and experience
  • Strong influencing and collaboration abilities
  • Experience working effectively in a matrix environment with multiple stakeholders
  • Knowledge of pharmaceutical and regulatory development processes

Responsibilities

  • Lead medical and scientific guidance for 5-8 Global Clinical Program Leaders
  • Ensure adequate portfolio resourcing with other Global Clinical Leads
  • Mentor clinical drug developers and physician teams
  • Define global clinical development strategy for therapeutic area
  • Contribute to business development strategy and due diligence
  • Prepare and support regulatory submissions and agency negotiations
  • Drive excellence in clinical development execution and strategy

Benefits

  • Opportunity to lead a dynamic team in clinical development
  • Engagement with KOLs and external authorities
  • Mentorship and professional development opportunities
  • Contribution to groundbreaking therapeutic area initiatives
  • Visibility and influence at industry key forums
Full Job Description

Reporting to theHead, GlobalClinical Developmentthe Global Clinical Lead(GCL)will act in a key leadership role in theClinicalDevelopment(CD)group;

  • Providing strategic and tacticalMedical& Scientificleadership and guidance for clinical development activities for 5-8Global Clinical Program Leaders (GCPL)

  • Serving as the CDrepresentative on theTherapeutic Area Leadership team (TALT)forCVRTA

  • Mayact as any of the following roles in clinical development:GCPL, Early Clinical Development Lead, BusinessDevelopment (BD)Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Leadas appropriate forprojects asassigned per business need

Main Responsibilities and Accountabilities:

GCL Line Manager responsibilities include:

  • Providing strategic and tactical medical leadership and guidance for clinical developmentactivities infor 5-8GCPLs
  • Works withother GCLsand head of clinical to ensure adequate resourcing across the portfolio
  • Manages team ofclinical drug developers, acts as a mentor to physician group in guide clinical developmentexpertisein general and in specific areas of therapeutic knowledge

GCLTALTCDRepresentativeresponsibilitiesinclude:

  • Definingtheglobal clinical development strategy for all projects in TA
  • Contributing to BD strategy & due diligence for TA &identifiesand evaluates NPOs
  • Ensuringhigh quality clinical & scientific content is providedintoRegulatory submissions & ensures defense and negotiation with Regulatory agencies
  • Preparingfor stage-gate evaluations and benefitrisk evaluations and assessments
  • Overseeingand supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and GlobalProjectLeaders toensureoptimalclinical strategy,CDPandprotocol design to supportoptimalProject strategy

GCL Other Responsibilities include:

  • Be an active member of the Clinical Development Leadership Team, improving the overall qualityof the group and its deliverables
  • Ensuringthat the patient and physician voice is at the forefront in strategy development
  • Buildingnetworks with external experts
  • Drivingexcellence in clinical development execution
  • Partneringwith TA core, extended core & functional partners to ensure scientific & medically robust clinicaldev & med affairs activities
  • Enhancingthe reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA
  • Representingthe Co & TA externally with KOL, HealthTechnologyand external authorities at key forums
  • Ensuring effective presentationsat Scientific andTechnicalReviewCommittee
  • Representingthe clinical function on the TALT, responsible for input intoTALTstrategy,overseethe quality of clinical plans in theCVRTA.

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 TAisa must.
  • Clinical development experience leading a therapeutic area or complex clinical program with aworking knowledge of pharmaceutical and regulatory development processes is essential

  • A minimum of8-10yearsexperience preferred,acquiredin 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; particularlydemonstratedability to work across the critical interfaces between Clinical andnon-Clinicalfunctions

  • Experience interacting with Health Authorities and designing programs that meet the needs of HAs,commercialand payers

About CSL Limited

CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
Learn more about CSL Limited
Size
25,000 employees
Industry
Founded
1904
NASDAQ

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