Director, Government Operations Strategy (Operational Strategy Lead)

Emmes Group•Rockville, MD

2d•Remote

About The Position

At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The Director, Government Operations Strategy (GOS) is responsible for collaborative development and implementation of operational strategies for Government prime, Government subcontractor, and public-private partnership (PPP) business opportunities with NIH, Upper-level HHS (BARDA, CDC, HRSA, FDA, etc.), DoD, VA, academic research organizations and centers, non-profit funders, and small to medium-sized Biopharmas receiving Government funding. This position will support the development of operational strategies for full-service clinical trials, multi- and single-service clinical trial support, statistical and data coordinating centers (SDCCs), clinical coordinating centers (CCCs), and other related opportunities. This support will include reviewing RFP/RFA documents and/or protocol documents to select the proper internal budgeting type and tool (e.g., CPFF, T&M, FFP, Fixed Unit Price, etc.), developing specifications and assumptions to enter into the budgeting tool, optimizing budget outputs based on study/project complexity and price to win strategy, identifying optimal subcontractors and vendors, and collaborating with Government Pricing, Proposals, and BD/Capture teams to ensure the Technical and Business Volumes align. The GOS will support bids from pre-RFP capture planning to initial proposal through competitive range negotiations/revisions (equivalent to the BDM stage) and knowledge transfer to the Government delivery team.

Requirements

Bachelor's Degree Scientific discipline. Required
5+ years progressive experience in project management and/or clinical operations on Government or PPP projects. Required
5+ years previous experience contributing to the development of Government or PPP budgets (CPFF, T&M, FFP, etc.). Required
Excellent verbal and written communication skills. High
Proven ability to meet critical deadlines. High
Collaborative team member to all colleagues within Emmes. High
Analytic aptitude. High

Nice To Haves

Master's Degree Scientific discipline. Preferred
5+ years previous experience within various areas of SDCCs, clinical operations, and/or full-service clinical trials. Preferred

Responsibilities

Optimizes and oversees operational strategy development and implementation for full-service clinical trials, multi- and single-service clinical trial support, SDCCs, CCCs, and related opportunities for all projects/studies that will be delivered by Emmes Government.
Develops operational strategy (or solution strategy) and gathers input from internal Scientific Directors, Project Leaders, and other SMEs. This includes identification of all subcontractors/vendors for the delivery of a project.
Collaborates across functional groups to assess and mitigate operational risks in the development of the clinical strategy, potential recruitment rates and overall timelines for scope of work.
Works with Government Pricing to optimize budgeting tools and models, including CPFF, T&M, FFP, Fixed Unit Price, etc.)
Provides budget inputs and works with pricing team to balance solution costs against price-to-win strategy.
Coordinates site budget and investigator grant estimates when needed via Medidata Grants Manager.
Liaises with resourcing heads to identify Key Personnel and non-Key Personnel per the SOW and within Sponsor timelines.
Collaborates with BD/Capture Manager and Vendor Management team to drive subcontractor/vendor selection process. Develops a subcontractor/vendor checklist at the beginning of the bid process, develops subcontractor/vendor Data Calls and RFPs based on prime RFP/RFA or protocol content, and provides Data Call with assumptions to BD/Capture Manager and Vendor Management team to obtain quotes and other required proposal input (e.g., central laboratory, regulatory support, etc.).
Supports BD/Capture and Proposal Manager in developing differentiated win strategies specific to the opportunity and customer.
Writes clinical delivery content across the Technical and Business Proposals (i.e., site strategy, operational challenges, lessons learned, best practices, staffing strategy, recruitment rates, monitoring strategy, timelines, competitive landscape, reporting, etc.) to deliver cohesive and compelling proposals to potential clients.
Collaborates with the Emmes Site and Patient Access Department to obtain customized Data Packs and clinical site strategy and enrollment projections.
Develops Smartsheet or MS Project integrated master schedules/work breakdown structures (IMS/WBS) for applicable opportunities.
Leads the development of BDM slides to include standard clinical delivery strategy.
Participates in client calls, competitive range negotiations/bid defenses, and relevant conferences.
Optimizes handover process upon award to project leadership. Prepares clinical and project management team for launch of project activities.
Works with Government Operations to implement program/project staffing strategy.
Identifies, reviews, and tracks departmental Objectives and Key Results.
Provides mentorship and guidance to team members.
Contributes to cross functional corporate initiatives.
Develops strategic relationships to improve Emmes access to sites and patients.