Global Clinical Lead- Hematology

CSL•Waltham, MA

About The Position

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. This role provides strategic and tactical Medical & Scientific leadership and guidance for clinical development activities for 5-8 Global Clinical Program Leaders (GCPLs). The GCL will serve as the CD representative on the Therapeutic Area Leadership team (TALT) for CVR TA. The GCL may also act in various clinical development roles such as 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 assigned projects based on business needs.

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.

Responsibilities

Providing strategic and tactical medical leadership and guidance for clinical development activities 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 guiding clinical development expertise in general and in specific areas of therapeutic knowledge.
Defining the global clinical development strategy for all projects in TA.
Contributing to BD strategy & due diligence for TA & identifies and evaluates NPO’s.
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.
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.