Global Clinical Lead- Hematology

CSL Vifor; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

CSL Vifor is seeking a senior Clinical Development Leader to provide strategic medical leadership for global clinical development activities and to serve on the Therapeutic Area Leadership team for CVR TA. The role guides GCPLs, coordinates with GCLs, and ensures robust medical input across regulatory interactions.

Experience in BD due diligence and matrix leadership is essential. The position requires MD with board certification, 8–10+ years in clinical development, and a proven ability to

Qualifications

• MD with board certification; subspecialty in CVR TA highly preferred.
• Experience leading therapeutic area or complex clinical programs.
• Strong track record in regulatory development processes and HA interactions.
• Proven leadership and collaboration across matrix organizations.
• 8–10+ years in industry or academia with sponsor exposure.

Responsibilities

• Provide strategic and tactical medical leadership for clinical development.
• Represent CD on the Therapeutic Area Leadership team for CVR TA.
• Mentor physicians and ensure resource adequacy across portfolio.
• Define global clinical development strategy and contribute to BD due diligence.
• Ensure high quality clinical content for regulatory submissions and reviews.
• Support stage-gate and risk–benefit assessments and cross-functional alignment.

Skills

MD

Board Certified

Clinical leadership

Influencing ability

Collaboration skills

Leadership experience

Matrix environment

Health Authorities interaction

Education

MD, Board Certified

Subspecialty in TA preferred

Job description

Main Responsibilities and Accountabilities:

• Providing s trategic and tactical M edical & Scientific leadership and guidance for clinical development activities for 5-8 Global Clinical Program Leaders (GCPL)

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

• May act as any of the following roles in clinical development: G CPL, Early Clinical Development Lead, B usiness D evelopment (BD) C ontributor, 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

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:

• Defin ing the global clinical development strategy for all projects in TA

• Contributing to BD strategy & due diligence for TA & identifies and evaluates NPO ’ s

• Ensur ing high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agencies

• Prepar ing for stage-gate evaluations and benefit –risk evaluations and assessments

• Oversee ing and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global P roject Leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal Project strateg y

GCL Other Responsibilities include:

• Be an active member of the Clinical Development Leadership Team, improving the overall quality of the group and its deliverables

• Ensur ing that the patient and physician voice is at the forefront in strategy development

• Build ing networks with external experts

• Driv ing excellence in clinical development execution

• Partner ing with TA core, extended core & functional partners to ensure scientific & medically robust clinical dev & med affairs activities

• Enhanc ing the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA

• Represent ing the Co & TA externally with KOL, Health Technology and external authorities at key forums

• Ensuring e effective presentations at S cientific and T echnical R eview C ommittee

• 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