Sr. Director, Compound Operational Lead

EMD Serono Research & Development Institute•Billerica, MA

24d•Hybrid

About The Position

The Compound Operational Lead (COL) is a global strategy program-level role within Global Development Operations (GDO). The COL will provide operational oversight, leadership and strategic input for the planning and execution of clinical program(s). In close partnership with cross-functional teams the COL will lead the clinical program, from First-in-human (FiH) to the final launch of the asset. The COL will drive faster, cost efficient, patient-centric trials that follow benchmarked industry standards that utilize “state-of-the-art” clinical project management methodologies aligned to global drug development processes. This role is accountable for the successful preparation and presentation of operational content at key governance discussions, ensuring critical operational input is provided to drive comprehensive, strategic, and thoughtful discussions for assigned program(s).

Requirements

Candidate must have a minimum of a BA or BS degree; Advanced degree in Life Sciences (such as a graduate degree) (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent medical background.
At least 12-15 years of direct experience with independently leading and managing very complex global clinical trial program(s) across multiple indications in the pharmaceutical industry plus 5-7 years in a senior leadership position directing the operations of a large-scale global team and developing and mentoring junior/mid-level team members in matrix environment.
Requires extensive project management experience in potentially diverse project settings. Also requires (considerably) deep and broad expertise combined with in-depth knowledge of competitors as well as challenges and developments in the industry to achieve objectives and to identify business opportunities.

Nice To Haves

Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
Broad clinical operations experience and strong project management skills
Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
Comprehensive expertise in drug development, including profound knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/ marketing)

Responsibilities

Leads the development of the clinical operational strategy (comprising of multiple trials, and/or multiple indications) and delivers the clinical development plan within the budget, timelines and quality standards agreed upon by Governance Committees.
Represents GDO within the Global Program Team (GPT) and serves as the key GDO operational point of contact for the program.
Accountable for the successful preparation and presentation of operational content at key governance discussions (Development Unit (DU), Program & Portfolio Governance (PPG), Integrated Protocol Review Committee (iPRC), Research & Development Committee (R&DCM), etc).
Key contributor to the development of annual program objectives and communicating to relevant line management.
Drives and leads the successful execution of all operational components of (a) global clinical program(s) using strong project management, leadership, and organizational skills.
Ensures strong oversight, review, and quality delivery of program CAPAs to meet corporate compliance standards and timelines.
Provides expert leadership and contribution to all operational aspects of the program budget, including oversight of individual trial budgets and forecasts to ensure delivery within the R&D financial standards.
Performs high-level review and provides input in the development of key clinical trial documents such as protocols and Clinical Study Reports (CSRs) and contributes to and/or reviews compound level documents such as Investigator Brochures, DSURs, briefing books.
Provides guidance and leadership support to Global CTLs and other cross-functional members within the assigned program/project.
Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operation and organizational challenges.
Supports the development and implementation of department initiatives including input on certain SOPs, processes, and workstreams.
Manages large, diverse projects with high or even unique complexity. Leads a large diverse project team with members from multiple functions and a broad span of levels and roles or even disciplines.
Accountable for successful project execution and organizational learning. Controls sizable resources and works independently. Also defines team organization, roles, and responsibilities as well as budget.
Contributes to the overall strategic decisions for a program(s) and drives the clinical operations aspects of the strategy within the cross-functional program team and various clinical sub-teams.
Develops innovative clinical operation strategies (including patient access and feasibility plans) across multiple indications, trials, and geographies.
Leverages strategic knowledge and serves as subject matter expert across TA portfolio for current drug development/clinical trial management processes, regulations, and therapeutic knowledge.
Leads the Clinical Operations Team (and potentially multiple teams or a sizable team of professionals/managers/team leaders) and is accountable for the performance and results of the team within a matrix environment internally and externally.
Assess resource needs and makes recommendations for allocations across the program(s). Contributes to setting team member objectives, coaching, and developing employees, performance appraisal feedback.