Director, Government Operations Strategy (Operational Strategy Lead)

Overview

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.

Bachelor's Degree Scientific discipline. Required

Master's Degree Scientific discipline. Preferred

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

5+ years previous experience within various areas of SDCCs, clinical operations, and/or full-service clinical trials. Preferred

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

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

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

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