VP, Clinical Development, Amyloidosis and Rare Cardiology

This is what you will do:

The Vice President, Clinical Development, Amyloidosis & Rare Cardiology will be a seasoned industry leader with primary responsibility for guiding and executing the strategic direction of development products and programs within Alexion’s Amyloidosis & Rare Cardiology franchise across all stages of development. The incumbent will implement clinical trial execution through strong leadership and collaboration with corporate functions and key internal departments, with accountability for the full scope of clinical development functions from post-PoC to BLA / NDA / MAA in accordance with the Company’s R&D Strategy.  This individual will provide strategy and leadership from the perspectives of effective and efficient development and will foster productive, collaborative relationships and work closely with core team members, functional leads and other colleagues to ensure their buy-in and knowledge-sharing in establishing and implementing the global development strategy for assigned projects. productive, interactive relationships. This individual will also be instrumental in defining drug development priorities and in serving as primary resource for all clinical activities, broadening the clinical platform and driving the clinical development of Alexion’s Amyloidosis & Rare Cardiology pipeline through anticipated rapid growth. This is a hands-on position that is expected to deliver top quality development activities in a timely manner.

You will be responsible for:

• Will include, but not be limited to, the following:

• Provide robust, innovative, visionary leadership for global clinical development and guidance in the design and construct of development plans; outline a clear pathway for the Company's compounds to enter the clinic and to pass expeditiously through the various phases of clinical drug development.

• Coordinate and lead cross-functional R&D input into Business Development (“BD”) opportunities within the Amyloidosis & Rare Cardiology space, including technical due diligence assessments.

• Provide leadership in establishing strategic clinical direction through active participation and leadership at senior levels to determine global strategies for products and disease area.

• Lead the global project team and review development plans through product lifecycle management.

• Oversee execution of clinical trial protocols with primary accountability for conduct of assigned trials, including collection and interpretation of data and patient safety information and ensure clinical plans are developed to deliver well-designed studies on time, within budget and with full understanding of the risks and opportunities.

• Provide clinical leadership to the Regulatory Affairs group to ensure sound regulatory practices are fully integrated into studies from preclinical, clinical development, commercialization and post-marketing activities.  Assist in identifying regulatory risks, developing strategies to minimize risks, and in guiding development program planning to anticipate changes in the regulatory environment.

• Ensure scientific data analysis, interpretation, and reporting are prepared and available in a timely manner for clinical sections of key regulatory documents as well as for other forms of data dissemination.

• Oversee the design, preparation and initiation of study protocols and required documentation in compliance with GCP and GMP; hold final responsibility for designing development programs and carrying out clinical trials on optimum patient populations.

• Provide clinical input to support the BD Team in deal evaluation and collaborate with the BD group to align on long-term strategy, create synergies, and share research and intelligence on innovative biotechnology and therapies, to advance the company’s growth strategy.

• Work collaboratively with all R&D groups, as well as BD, Competitive Intelligence and New Products Planning, to establish major research collaborations and partnerships aligned with corporate and R&D strategy.

• Have accountability for identifying and assessing value creation activities as part of the Company’s R&D strategy; set, manage and monitor overall goals for R&D External Innovation activities.

• Establish a solid, R&D supported clinical development plan that provides insight into the established drug discovery and development process.

• Cultivate relationships and establish and maintain a strong network of peers within the industry.  Be on the front line with key opinion leaders, thought leaders and other key medical experts in the relevant academic medical community.  Represent Alexion as a senior medical spokesperson before appropriate scientific, medical, regulatory, business and ot