Vice President Research And Development

Ora, Inc. in Andover, MA

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
Background: As an award-winning market leader in the field of Ophthalmology, Ora offers exciting opportunities for top-performing professionals. We provide clear career progression opportunities and invest in training and developing our talent. Our leadership roles are ideal for those high performing executives looking to build teams, organizations and drive growth in an exciting and progressive company. Summary of Position: We are seeking a multifaceted and driven individual with a strong scientific background and relevant expertise in ophthalmology with a focus on both the anterior and posterior segment. The role will report directly to the CEO and as a key member of a highly scientific team, the VP of the R&D Institute will be involved in routine interactions with senior management, clients, regulatory authorities, and consultants. This person will be solely focused on internal R&D efforts. In that light they are fully accountable for the annual planning, execution, and management of Ora’s R&D Institute. The efforts for the R&D team are developed cross functionally and underpinned by commercial need. At Ora the R&D team focuses on the development of novel endpoints, ophthalmic technologies for use in clinical research and other innovations that continue to put Ora at the forefront of innovation within the pharmaceutical services space. This person will collaborate horizontally and within the organization with many different stakeholders such as therapeutic leaders, legal, the commercial organization, quality and IT. This position will be expected to provide project leadership and be fully responsible for all deliverables including: comprehensive global project development plans, ensuring that all support functions are adequately resourced, achieving project milestones, developing and maintaining realistic project budget forecasts, leading the preparation process of regulatory documents, and heading up all communication and publications. This scientific leader is expected to be a project driver and have a full understanding of the scientific landscape. He/She is also involved in researching, writing, and editing materials for regulatory submission, publications and trade journals. The successful candidate will be able to work in a fast-paced, team oriented environment while still maintaining a high standard of scientific excellence. PRIMARY RESPONSIBILITIES: Develops comprehensive project development plans that are consistent with the therapeutic area strategy, and that are scientifically sound, innovative and efficient. Delivers projects on time and on budget, and in compliance with all regulations and SOPs; is responsible for timely communication of project related critical issues/events. Designs, manages and executes research studies or addresses mechanism of action based experiments with the goal of developing novel endpoints for human eye diseases. Contributes towards business development opportunities to promote scientific collaborations and partnerships as required for endpoints or technologies developed within the institute. May work with research groups to identify compounds with suitable drug-like properties for human clinical evaluation and to evaluate ophthalmic drug targets. Seeks out opportunities for new data analysis and scientific improvements. Recommends system upgrade, new system implementation, and process improvement as necessary. Provides scientific support for client presentations, due diligence activities, and strategic planning activities as requested. Works collaboratively with project teams and interdisciplinary teams across the organization. Liaise with functional areas (e.g. therapeutic area heads, data management, CMC, business development) on initiating, planning, executing, and resourcing research studies. Supports the medical writing of abstracts, posters, manuscripts from clinical trials and coordinates internal and external reviews and collate reviewers’ comments. Conducts literature searches and interprets scientific literature and then prepares analyses, interprets, and summarizes data and evaluates study data from tables and listings. Supports in reviewing medical and scientific content for accuracy and positioning on key regulatory documents, publications and slide presentations Manages review and revision processes for multiple, concurrent projects Ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs Develops the annual budget and research plan in conjunction with Ora’s leaders and research efforts. Manages departmental team, P&L and strategic planning efforts for the R&D Institute. REQUIRED SKILLS AND ATTRIBUTES: Extensive hands-on experience and in-depth knowledge in ophthalmology is required. Must have a proven record of success as demonstrated by publications, presentations and academic and preferably pharmaceutical experience. Excellent writing, presentation, organizational and written/verbal communication skills. Prior experience with and knowledge of regulatory requirements/guidelines with broad technical knowledge to review scientific reports for IND submissions. Knowledge of FDA and ICH guidelines and GCP compliance. Demonstrated leadership skills for team building, facilitation, problem solving, conflict resolution and negotiation. Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and scientifically while balancing short-term and long-term company objectives. Ability to work effectively across multiple functions, at all levels of management; lead multidisciplinary project teams and maintain project schedules on multiple programs. Strong project management, interpersonal, communication, negotiation and problem solving skills. Ability to work well in a team environment, with the ability to also work effectively independently. Strong external network and publication track record. OTHER REQUIREMENTS: PhD in vision sciences or transferrable life science discipline, with 15+ years of medical, regulatory, or clinical experience in the field of ophthalmology in the pharmaceutical, device or biotech industry, or equivalent training and work experience.

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