· M.D. with a specialty in Neurology is preferred; Ph.D. or PharmD with neuroscience 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.