VP, Clinical Development, Amyloidosis and Rare Cardiology

AstraZeneca•Boston, MA

19d

About The Position

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.

Requirements

M.D. with a specialty in Cardiology is preferred; Ph.D. or PharmD with cardiology expertise and requisite industry global clinical development experience will be considered.
Leadership skills encompassing line/project management and multidisciplinary program management experience, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA/FDA meetings.
10+ years’ extensive industry-related experience sufficient to demonstrate knowledge of all phases of drug development, registration and approval.
Demonstrated proficiency in the implementation, monitoring and management of clinical trials, timelines and budgets. Expertise in clinical program administration.
Demonstrated experience leading the development of at least one candidate with adherence to quality, excellence and efficiency is required; a record of success in securing drug approvals and a demonstrated ability to affect direction and decision-making within development programs and in regulatory agencies will be a plus.
Track record of success leading drug development projects and activities in a matrixed, global organization.
Knowledge of leading edge drug development and commercialization and perspective on the entire cycle of drug development, from “first in man” through pivotal trials; sufficient real-world experience to take charge of and complete the necessary steps to secure product registration for the Company’s drug candidates.
Strong knowledge of regulatory requirements and good clinical practices; experience in reviewing clinical protocols and studies to ensure execution and compliance with FDA standards and regulations.
Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings – IND/IMPD, BLA/NDA/MAA.
Experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA Advisory Committees, focusing on the key strategic issues.
Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance); what needs to be evaluated simultaneously vs. sequentially, etc. from a strategic planning/risk management time/event/cost point locally and globally.
Firm understanding of how best to educate, advise and implement with respect to Regulatory Guidances, internal Standard Operating Procedures and Project best-practice behaviors.
A highly effective communicator with the ability to credibly develop and articulate a sound vision of the Company's development initiatives and science and its significance to the practice of medicine.
Experience working as a member of a senior management team and collaborating with cross-functional peers as well as with scientists, thought leaders and external decision-makers worldwide. Ability to align with internal and external stakeholders, from R&D through commercial leadership, market access and reimbursement experts.
Strong and transparent communications skills with proven influence and presentation skills
Ability to assimilate data, recognize key variables, analyze complex situations and make quality judgments.
A realistic expectation of the business, one’s self and others; demonstrated ability to inspire, manage and lead and to build alliances, both internally and externally.
A team player with a strong sense of “we” and a high degree of emotional intelligence who doesn’t confuse efforts for results.
A critical thinker proactive in approach both in bringing ideas to the table and in identifying potential issues and remedial actions. Tenacity to weather short-term setbacks for long-term advantages.
Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development. A hands-on, high-energy individual with strategic, operational and execution skills capable of accomplishing objectives.
A team player who works well across multiple areas of the business and can effectively communicate with scientific and non-scientific stakeholders.
An executive and scientific presence that enables him/her to present themselves and their ideas and opinions powerfully to colleagues at all levels.
Persuasive and self-confident with interpersonal skills that facilitate the building of effective relationships with senior leaders; collaborative and able to thrive in a team-oriented environment.
High emotional intelligence, self-awareness, and a charismatic personal style that fosters trust and respect so people desire to engage with them or actively seek them out.
Strong interpersonal, communication and listening skills; excellent presentation skills.
A proactive thinker and doer who actively seeks to discover and uncover potential trouble spots and acts before a situation develops into a problem. A “big thinker” and an active stimulating member of the senior management team.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Responsibilities

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 other professional meetings, as appropriate.
Set standards, establish clear expectations, and monitor delivery of excellent performance for all clinical development employees and activities. Serve as a key contributor in the appraisal of core team members.