Senior Director, Global Operations Strategy - ...

Overview: Senior Director, Global Operations Strategy - Ophthalmology US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. Were looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us! Primary Purpose The Sr. Director, Global Operations Strategy-Ophthalmology is responsible for joint development and implementation of global commercial processes and leading the development of a differentiated win strategy for business opportunities focused on ophthalmic diseases. In addition, the Sr. Director, Global Operations Strategy-Ophthalmology will provide subject matter expertise regarding operational execution for ophthalmic trials, as well as ensuring optimal knowledge transfer of strategy to operations post award. The Sr. Director, Global Operations Strategy-Ophthalmology will identify recruitment strategies and support operations in the implementation of those strategies post award working very closely with all relevant stakeholder groups. Responsibilities: Optimizes and oversees the RFP to final proposal process specific to Ophthalmology. Improves the proposal template to ensure all key areas are included. Develops a vendor checklist to complete at the beginning of the bid process. Provides checklist with assumptions to proposal manager to obtain quotes (i.e., central laboratory, EDC vendor, etc.). Provides leadership to biopharma proposal writers/managers. Develops and implements the differentiated win strategy specific to the opportunity and customer. Implements global staffing strategy. Confirms strategy and proposals with the consulted SMEs. Collaborates across functional groups to assess and mitigate operational risks in the development of the clinical strategy and potential recruitment rates and overall timelines for scope of work. Writes clinical delivery content in the proposal (i.e., site strategy, operational challenges, lessons learned, best practices, staffing strategy, recruitment rates, monitoring strategy, timelines, competitive landscape, etc.) to deliver cohesive and compelling proposals to potential clients. Tracks site budget and investigator grant estimates when needed via Medidata Grants Manager. Participates in bid defense meetings and/or coaches staff for such meetings and assists with BDM strategy. Works with marketing to optimize the BDM slides to include standard clinical delivery strategy. Continues to identify systems/processes Emmes needs to grow capabilities and services to keep Emmes at the forefront of the changing landscape of the clinical research industry. Participates in the Ophthalmology TA as a subject matter expert. Identifies target customers. Participates in client calls, bid defenses and relevant conferences. Optimizes handover process upon award to clinical operations and other stakeholders. Liaises with resourcing heads to identify staffing per the statement of work and within Sponsor timelines. Develops and implements process for project kick-off. Prepares clinical and project management team for launch of project activities. Collaborates with the Emmes Site and Patient Access Department. Provides input on the development site networks for Emmes largest therapeutic and research units. Consults with designated site SMEs on bids (i.e., operational or recruitment challenges, site budgets, etc.) when needed. Provides input on the development of network and relationships with patient advocacy groups and recruitment vendors. Identifies, reviews, and tracks departmental Objectives and Key Results. Provides mentorship and guidance to team members. Contributes to cross-functional corporate initiatives. Works to standardize biopharma activities. Develops strategic relationships to improve Emmes access to sites and patients. Performs other duties as assigned. Qualifications: Bachelor's degree with at least 7 years progressive experience in global clinical trial operations Previous experience leading a team of strategic professionals Previous experience within various areas of global clinical trial operations - specific to Ophthalmology . Previous experience and contracting with ophthalmic clinical trial sites. Excellent verbal and written communication skills. Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics. #LI-Remote

Created: 2024-11-05