Sr. Director Global Study Strategy and Optimization

Location
Tarrytown, NY, United States
Posted
Sep 17, 2019
Ref
17596BR
Required Education
Bachelors Degree
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.

Summary:
The Sr. Director Global Study Strategy and Optimization will be responsible for the concept, design, growth and deliverables of the integrated Study Start Up, Global Trial Optimization, eClinical Outcomes Assessments and Patient Innovation functions to assure the highest quality support for delivery of Development Programs on time, with high quality and within budget. The incumbent will be instrumental in aligning, overseeing, and developing these functional areas to enable predictable delivery of clinical study milestones. This role is also responsible for management and oversight of multiple vendors who supply systems, services, and functional support.

Included in the functional leadership scope are various trial support services including Study Start up sourcing and global infrastructure strategy and growth opportunities, feasibility, recruitment and retention, study planning and modeling, and site networking. The Sr. Director Global Study Strategy and Optimization is a member of the GCO senior leadership team, and as such interacts with senior level management, external vendors, collaboration partners and provides cross functional strategic direction and is accountable for building and managing teams across functions to identify risks and opportunities in Clinical Trial Execution and Innovative approaches to trial delivery.

The incumbent will play a key role in developing and maintaining relationships with partner functions/activities such as; Vendor & Relationship Management, Clinical Study Contracts & Budgets, Regulatory/Ethics committee/IRB interactions, Clinical Drug Supply and Logistics, and Regulatory Compliance. Importantly, this role will have significant interface with Clinical Trial Management Leadership roles to ensure high quality support for trial execution. It will also be critical to ensure cross-program consistency of early program and study operational planning in support of study design decisions and downstream study execution and timelines. Responsible for leadership and development of functional group deliverables, management, and team/staff development.

Responsibilities:

• Leadership and oversight for functional group deliverables, management, and team/staff development

• Oversee functional team responsible for program and study level feasibility strategy and processes

• Provide leadership for CRO and team partnerships across study strategy

• Oversee efforts to provide CTM teams recruitment support through internal and vendor efforts.

• Oversee functional strategy for external engagement (i.e. patient, site,vendor and collaborations)

• Lead and develop strategy for the development of a study start up team responsible for ensuring and overseeing the successful and on-time delivery of study start-up tasks and coordination including sourcing strategy and internal infrastructure management

• Lead the functional team responsible for the definition, implementation, and management of electronic Clinical Outcomes Assessments (eCOA) across Global Development

• Oversee strategy for development of Patient Innovation to ensure 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.

• Participate and provide input into a range of continuous improvement activities to ensure consistency of GCO process execution.

• Drive the strategy for development and implementation of all direct report functions through process initiatives and change management activities.

• Collaborate with Clinical Sourcing and Vendor & Relationship Management to provide functional input into the identification, qualification and relationship management of vendors utilized

• Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution. Identify and leverage external knowledge of industry best practices, processes and new trends

• Oversee the Global Study Strategy and Optimization functions in accordance with company SOPs, FDA, & ICH guidelines and regulations.

• Responsible for development of key metrics and dashboards to highlight trends and areas for continuous improvement or functional contribution deficiencies as well as provide updates to management.
Requirements:

Education

• Bachelor's Degree

• Advanced Degree Desirable

Experience

• 15+ years' of related industry experience

• 15+ years of functional leadership

• 10+ years people management

Travel

• Up to 30% Travel

• Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval

• Compelling communicator with ability to translate complex messages to a variety of audiences.

• Proven ability to build strong working relationships in a diverse range of team environments

• Experience in utilizing data to inform clinical strategy development

• Ability to understand complex business questions and develop effective solutions

• Experience in process development, implementation and change management activities

• Thrives in a highly dynamic environment where creativity is key in meeting the needs of key stakeholders

• Self - motivated, good interpersonal and leadership skills, a team player

• Line management 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.