Head, Clinical R&D, Vision Care

Overview of the role

The candidate will lead 2 major groups within the Global Clinical R&D (CRD) Center of Excellence (CoE)

1) CRD Vision Care (VC) portfolio: Directors and Senior Clinical project leads responsible for strategic planning, development, and execution of clinical trials for product registration worldwide and/or post market product support and competitive differentiation in full alignment with the overall business imperatives. VC includes all products in the contact lens portfolio, contact lens care, refractive correction (myopia), novel contact lens materials, feasibility clinical studies in Alcon Research Clinics in Duluth, Georgia and Fort Worth, Texas.

2) Clinical Evaluation: Group Heads and Scientific Clinical evaluation specialists responsible for the management of clinical documentation throughout the lifecycle management process, specific for VC products, including planning, execution, and reporting of clinical evaluations and any related postmarket clinical follow up studies

Collectively, the number of associates that report into this position (directly and indirectly) would be up to 50.

The associate will serve as the key Clinical and Medical strategic partner for the VC Global Franchise Head and for the VC Therapeutic Platform Leader in Global R&D. Be responsible for all aspects of Alcon initiated clinical trials (AITs) in both clinical R&D, and global medical affairs for all products in Alcon CRD VC therapeutic platform. Be a member of the Global Clinical R&D Leadership team, CRD VC R&D Leadership Team, participate in the Protocol Review Committee as the medical/clinical partner. Teams working in this group will serve as the primary point of contact for R&D pipeline project teams during all stages of product development & launch, be the key CRD partner for global medical affairs teams, support global medical training, working closely with Global Professional Affairs, to all customer facing medical associates worldwide.

 

Key Responsibilities

Lead and matrix manage Clinical Project Leaders, Clinical R&D Directors (JL3) and Associate Directors (JL4) and their direct reports to develop high quality global medical evidence plans, pre & post registration (Phase I – IV) in all stages of the medical device development, for the specific product area(s) in the device pipeline in full alignment with the Franchise imperatives.

Accountable for resourcing and forecasting of all clinical R&D activities (studies, collaborative research agreements, feasibility clinical activities in the Alcon Research Clinics) across the VC portfolio, developing realistic trial budget forecasts and for timely execution of clinical studies and for the reallocation of resources as required to meet targets. Ensuring high-quality, scientifically-sound clinical protocols and related documents that produce clear, decisive results. Accountable for planning/conduct/reporting on clinical studies at the Alcon Research clinics in Fort Worth and Duluth in collaboration with the Clinical Staff and reporting results to VC and CRD Management. Accountable for Clinical Trial Strategies to support product approval, value-based brand positioning, competitive differentiation, market access and reimbursement including scientific review and approval of global and regional investigator-initiated studies (as needed) and independent medical education requests Lead and matrix manage the clinical development aspect for project/program teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures; report study progress and issues with their resolution plan. Accountable, across all VC, for medical/scientific review of clinical trial data, final analysis, and interpretation within clinical trial reports, publications, and internal/external oral and written presentations. Accountable to lead and matrix manage the clinical evaluation team for VC, supervising/mentoring Group Heads, clinical evaluation specialists located in AGS, India. Activities include but not limited to, understanding, and evaluating available clinical data (on the specific portfolio), reviewing data against MDR and MDCG Guidance documents and conducting gap assessments, post market clinical follow up activities (plan/conduct/report), and remediation activities. Primary point of contact for the regulatory team for the life cycle management activities. Participate in the on-boarding and training of new Clinical R&D staff and for mentoring new project/program team members as needed. Stay abreast of relevant literature and clinical practice norms for the project/program area(s) Attract and develop top talent. Effectively manage team’s performance and talent related processes such as succession planning, compensation and rewards. Responsible as the key medical and clinical reviewer on External Technology Reviews related to VC and providing key input to the Franchise on technical evaluations of external technologies and to the Executive Leadership Team in decision making regarding external acquisitions.

Minimum Requirements

• Education: Masters or PhD Degree in Health Sciences.
• Experience: 15 years of relevant experience and 5 years of demonstrated leadership in managing complex therapeutic areas/portfolio(s), leading and managing regulatory submissions in US and OUS, Extensive experience in medical ophthalmic devices, especially contact lenses and vision care therapeutic areas, demonstrated expertise in vision science/optometry/ophthalmology
• Ability to fluently communicate in English (verbal and written)
• Strong project management skills with ability to prioritize, manage multiple projects, and delivering results in a tight timeline
• Excellent interpersonal and communication skills with a demonstrated ability to build and maintain effective cross-functional partnerships
• Deep understanding of global regulatory needs, life cycle management, medical device regulations, remediation, and experience in working with large teams in preparing and submitting regulatory documents to notified bodies

Proven experience in leading large, cross functional teams in a matrix organization, with a track record of successful project and milestone delivery

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