Senior Director, Global Operations Strategy - Ophthalmology

The Emmes Corporation - Rockville, MD

Full-time - Senior

Remote - Rockville, MD

Professional, Scientific, and Technical Services

About the position

The Senior Director, Global Operations Strategy - Ophthalmology at Emmes Group is a pivotal role responsible for the joint development and implementation of global commercial processes specifically tailored for ophthalmic diseases. This position requires a strategic leader who can craft a differentiated win strategy for business opportunities in the ophthalmology sector. The Senior Director will leverage their subject matter expertise to ensure operational execution for ophthalmic trials, facilitating optimal knowledge transfer of strategies to operations post-award. This role is crucial in identifying recruitment strategies and supporting operations in their implementation, necessitating close collaboration with various stakeholder groups. In this role, the Senior Director will optimize and oversee the Request for Proposal (RFP) to final proposal process, ensuring that all key areas are included in the proposal template. They will develop a vendor checklist to be completed at the beginning of the bid process and provide this checklist along with assumptions to the proposal manager for obtaining quotes from relevant vendors. Leadership will be provided to biopharma proposal writers and managers, guiding them in the development and implementation of a differentiated win strategy tailored to specific opportunities and customers. The Senior Director will also collaborate across functional groups to assess and mitigate operational risks associated with the clinical strategy, recruitment rates, and overall timelines for the scope of work. They will be responsible for writing clinical delivery content in proposals, which includes site strategy, operational challenges, lessons learned, best practices, staffing strategy, recruitment rates, monitoring strategy, timelines, and competitive landscape, ensuring that proposals are cohesive and compelling for potential clients. Additionally, the Senior Director will track site budgets and investigator grant estimates as needed, participate in bid defense meetings, and coach staff for these meetings. They will work closely with marketing to optimize Business Development Manager (BDM) slides, ensuring that standard clinical delivery strategies are included. The role also involves identifying systems and processes that Emmes needs to grow its capabilities and services, keeping the company at the forefront of the clinical research industry. As a subject matter expert in the Ophthalmology Therapeutic Area (TA), the Senior Director will identify target customers, participate in client calls, bid defenses, and relevant conferences. They will optimize the handover process upon award to clinical operations and other stakeholders, liaise with resourcing heads to identify staffing per the statement of work, and develop processes for project kick-off. The Senior Director will prepare clinical and project management teams for the launch of project activities and collaborate with the Emmes Site and Patient Access Department. They will also provide mentorship and guidance to team members, contribute to cross-functional corporate initiatives, and work to standardize biopharma activities while developing strategic relationships to improve Emmes' access to sites and patients.

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.

Requirements

• 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.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment