Scientific SME

Imaging Endpoints (IE) is an ImagingTechnology and ImagingClinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with thissingular purpose. We work everyday excited to advance imagingscience, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talentedindividuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpointsis based in Scottsdale, Arizona,with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

We are seeking a Scientific Subject Matter Expert (SME) to join our Business Development Operations team at Imaging Endpoints. This role will focus on developing high-quality proposals and contracts, aligning them with study protocols, and integrating scientific best practices. The SME will also represent Imaging Endpoints in client meetings and industry conferences, supporting business growth and strong sponsor relationships.

RESPONSIBILITIES

• Manage the coordination and development of business proposals (request for proposal/request for information: RFP/RFI) and contracts for prospects and clients.
• Draft, review and assist with change orders, and revisions to those documents in accordance with timelines required.
• Optimize proposal design by identifying and clarifying opportunities and needs described in RFPs and associated documentation, specifically study protocol. Integrate IE experience, key differentiators, and other industry best practices into proposals and presentations.
• Identify and communicate risks associated with proposals and contracts.
• Meet proposal and change order deadlines by establishing target dates and identify priorities involved in information gathering, writing, review, and finalization.
• Ensure the preparation of quality assumption tables (ATs) to align with study protocol.
• Participate in or lead key internal and external meetings related to proposals and contracts as applicable.
• Conduct verbal and/or written follow-up after the submission of proposals as needed. Communicate to the IE team the outcome of the negotiations/proposals focusing on conveying the expectations for each group, i.e., critical timeframes and scope of work.
• Represent Imaging Endpoints in conferences and meetings with clients and prospective clients to present IE's capabilities, assist with proposal development, bid defenses, work order development, change order development and other business development activities as required.
• Represent IE by presenting at conferences and other industry meetings.
• Interact with, build relationships with and support sponsors and vendors.
• Perform other duties as assigned by the supervisor.

EDUCATION AND EXPERIENCE

• 2+ years in scientific/medical writing, proposal development, or contract management.
• 2+ years of experience in the pharmaceutical or a regulated industry.
• 2+ years of iCRO experience a must.
• Bachelor's degree in English, Journalism, Marketing, Communications, Business, Computer Science/MIS, Science, Law, or related area.
• Knowledge and understanding of 21CFR Part 11, Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP).

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints https://caringendpoints.org/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reachwith hands and arms andtalk and hear. The employeeis frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

TRAVEL

About 5 – 10 % travel (domestic and/or international)