Global Clinical Lead- Hematology

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 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

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