Associate Director, Clinical Operations Innovation Lead

Location
Sleepy Hollow, NY, United States
Posted
Aug 05, 2019
Ref
17077BR
Required Education
Masters Degree/MBA
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Patient Innovation Leader will be accountable for the successful delivery of novel technologies and fit-for-purpose solutions to maximize trial effectiveness and reduce trial burden to the patient for Regeneron's clinical research portfolio. The Patient Innovation Leader will be responsible for management and direction of Patient Innovation Managers and will have direct responsibilities for the maintenance of the lab space. The Patient Innovation Leader requires an entrepreneurial mindset, strong analytical and research skills, relationship management skills, presentation skills, creative thinking and problem-solving skills, and experience with the clinical trial process.

Responsibilities:

∙ Acts as a strategic leader, responsible & accountable for managing a portfolio of novel technologies and solutions to meet current and future state needs of Regeneron's clinical development programs

∙ Accountable for the development of business cases to progress innovative strategies at a trial, program or corporate level in collaboration with various business areas in Regeneron, including Global Development

∙ Develops, manages & oversees the conduct of innovation pilot projects and is responsible for implementation of solutions into Regeneron clinical development programs

∙ Responsible for maintaining cutting edge knowledge of developments in clinical measurements, latest innovations, clinical trial industry news, and advancing regulatory trends through conference attendance, open forums and developing external relationships

∙ Responsible for establishing partnerships with leading institutions in research (startups, academia, CRO) to collaborate on concept development and new technology adoption

∙ Responsible for establishing and fostering collaborations with internal stakeholders and vendors to strategize effective innovative solutions

∙ Conducts review of protocol development as it relates to sensors or other clinical technologies and provides guidance to Patient Innovation Managers related to protocol development

∙ Develops global best practices and/or Standard Operating Procedures to support adoption of different innovation technologies

∙ Accountable for oversight of financial components related to Innovation for clinical programs/studies

∙ Point of contact for escalation for teams and manages and resolves issues

∙ Acts as a change agent by communicating clinical innovations in eSource modalities to stakeholders and broader organization

∙ Facilitates and contributes to lessons learned, best practices

∙ Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development

∙ Responsible for direct supervision of staff

Requirements:

• Direct experience with health information technology and mobile applications is required

• Proven knowledge of, or experience with, clinical trial development process is required

• Knowledge of general system development processes is required

• Demonstrated interpersonal & leadership skills, including direct experience with strategic business development projects is required

• Must have strong leadership skills

• Must have excellent communication skills (verbal, written and presentation abilities)

• Ability to compiles and summarize complex data

• Ability to influence, negotiate, and drive decision making across matrixed organization

• Demonstrated vendor management experience

• Technical proficiency in trial management systems and Microsoft Project Server

• Knowledge of ICH/GCP and regulatory guidelines/directives

This role will require approximately 20% of travel, domestic & international.

Key Team Membership (including, but not limited to):

• Innovation Committee

• Global Clinical Subteam and/or Clincial Study Team

• Clinical Operations Review Meeting(s)

• Clinical Compliance Meeting(s)

Cross Functional Interfaces (including, but not limited to):

• COA Manager

• Clinical Study Lead, Program Operations Leader

• Medical Director(s)

• Health Economics & Outcomes Research

• Project Management

• Data Management, Biostatistics

• Procurement

• Clinical Finance

Masters degree and minimum of 10 years of relevant industry experience (ie. Pharmaceutical, Biotech, Clinical Research Organization).

Bachelors' degree and a minimum of 15 years of relevant industry experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.