Executive Director, Clinical Development

Role Summary

The Executive Director, Clinical Development will serve as a key member of the Company’s leadership and will have primary responsibility for the design and oversight of an integrated development strategy, including both in-house development and potential strategic partnerships to augment the internally developed pipeline. This position will provide comprehensive leadership of the development process from pre-IND studies through to NDA and Phase IV programs. The Executive Director, Clinical Development will be responsible and accountable for the development of the medical aspects of one or more clinical development program. This role will be responsible for delivering quality and timely medical input and interpretation on specific program data in fulfilment of the program objectives, working in partnership with regulatory affairs and pharmacovigilance in providing medical support for pharmacovigilance activities, responses to regulatory agency queries, and development.

Primary Responsibilities Include:

• Lead the Clinical Development team across planning, design, development, and implementation of clinical trials for the drug candidate
• Develop knowledge of disease mechanisms to select biomarkers, pharmacodynamic endpoints, and patient stratification considerations
• Develop and implement an effective, timely and cost-efficient development program to establish the safety and efficacy of drug candidate compounds to achieve approval in the US and other countries
• Develop protocols and study completion determinations
• Coordinate with the discovery group to assure smooth transitioning of development candidates/programs from research into development
• Provide pharmacovigilance oversight and manage timely reporting of safety signals to regulatory agencies
• Guide Research team on decisions that have clinical components and implications
• Identify, manage, and interface with external collaborators and key opinion leaders to create clinical development strategies for a novel class of therapeutics
• Provide clinical development oversight for Discovery and Development programs, including strategy, planning, execution, and completion of clinical trials according to all applicable regulations and guidance
• Collaborate with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance, maintaining the highest quality clinical programs, following GCP and ICH guidelines and the Company’s standard operating procedures
• Select between outsourcing and in-house approaches for Clinical Development capabilities and work closely with the Clinical Operations team to implement choices
• Manage relationships with third parties, such as CROs and outside collaborative partners, who are part of the clinical development efforts
• Serve as medical representative to regulatory agencies, our investigators, and advisors and as study medical monitor, as needed
• Participate as requested in Business Development due diligence and presentations to external constituencies
• Manage the writing of protocols, presentations, and publications (regulatory submissions, original peer-reviewed articles, abstracts)
• Review key documents including protocols, investigator brochures, and informed consent forms
• Maintain accountability for all relevant timelines and deliverables working closely with functional counterparts and colleagues on the integration of product and clinical development plans
• Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other departments and external vendors in order to ensure study objectives and timelines are accomplished
• Support the CMO with oversight and management of the department budget and financial planning
• Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
• Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
• Develop and implement SOPs for clinical trials and related activities, as required
• Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Legal, and Medical Affairs
• Develop and maintain professional relationships with academic and community-based study sites
• Represent the company in interactions with regulatory agencies
• Provide leadership and mentorship to clinical development team members, managing matrix and direct line reports

Education and Skill Requirements:

• Doctor of Medicine degree, PhD or Pharm. D., with a strong scientific background and a specialty in neurology or neuroscience training highly preferred
• Minimum of 10 years of pharmaceutical industry experience
• Experience leading a clinical development program(s) in Neurology/ Neuromuscular disorders
• Experience with all aspects of designing, executing, monitoring, and managing clinical trials from inception to completion across all phases of development
• Robust regulatory experience with Pre-INDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
• Experience managing significant accelerations and challenges in clinical programs
• Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
• Strong knowledge of FDA and ICH regulations
• Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines
• Expert knowledge of Good Clinical Practice (GCP)
• Experience in a small to mid-sized biotech company is preferred
• Proven track record of drug development with Phase 1 through 3 trial experience preferred
• Readiness to “roll up the sleeves” to contribute to team efforts
• Excellent writing skills with a track record of publications and polished presentation skills to influence internal and external audiences
• Ability to develop creative approaches to processes, practices, services, business models, and strategy
• Ability to translate basic science into a product development plan that will maximize the product’s commercial opportunity
• Ability to work successfully in a matrix environment and effectively build consensus
• Communication skills (written and verbal), which are equally effective internally and externally, with large and small audiences, and one-on-one’s
• Ability to effectively lead cross-functional meetings, and meetings with senior leaders to drive successful outcomes
• Ability to create and inspire high-performance clinical development team
• Ability to drive key actions at a high level of independence, working with staff, other senior leaders and designated external constituencies as necessary
• Ability to effectively plan near to long-term strategy to ensure that most important efforts are prioritized and driven aggressively
• Takes personal accountability for outcomes and thrives on increasing levels of responsibility to move the business forward
• Strong project planning, leadership, negotiation, communication, and presentation skills as well as a demonstrated ability to contribute creative yet practical solutions to problems