Job Description
This position provides expert strategic and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast paced, industry-leading, dynamic bio-pharmaceutical company. You will have both direct & indirect reports, managing team(s) across programs/within a disease area.
Responsibilities
•Leading and directing teams within a program/disease area/asset on key program planning and execution elements (e.g., program-level overviews; senior management and governance meetings).
•Providing operational input at the CST level during protocol design (e.g., feasibility, execution risk, operational implications of design choices) and on program-level development planning documents (e.g., Clinical Development Plan, Protocol Concept Sheet, Protocol), ensuring program-level consistency and delivery of program objectives.
•Developing and maintaining the Clinical Operations Project Schedule, defining timelines for key trial milestones (e.g., DBL), and providing ongoing operational oversight of trial plan deliverables (e.g., Central Lab plan, Specimen Management Plan).
•Providing program-, disease-area, or asset-level oversight & context to inform trial-level enrollment, site feasibility & selection, and leading patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders across trials.
•Conducting resource planning and staffing across a program, disease area, or asset (hiring and/or project onboarding; management of Trial Managers; may include management of other Program Leads).
•Holding overarching responsibility and oversight of program, disease-area, or asset-level execution, providing innovative ideas to achieve organizational objectives, tracking key trial milestones and metrics across the program, proactively managing delays, and surfacing execution risks.
•Leading efforts and applying expertise to maximize operational feasibility and efficiency, and ensuring consistency and quality across the assigned portfolio.
•Serving as the primary escalation point for trial teams on operational issues, fielding and resolving cross-functional issues, promoting cross-functional solutions, and escalating to management as needed.
•Partnering with Portfolio Sourcing & Relationship Management (PSRM) on program-level service provider strategy (e.g., selection, qualification, contracting, oversight), resolving escalated issues and promoting consistent standards across studies.
•Reviewing and providing expert operational input on trial-level regulatory submissions (e.g., IND, CTA, Article 46), Health Authority responses and meeting material, Risk Language, and the Clinical Study Report.
•Reviewing trial-level ADI/RAID logs, Quality Plans, and readouts from quality metric dashboards (e.g., protocol deviations, temperature excursions), and proactively identifying and minimizing operational risks across the program/disease area/asset (e.g., clinical supply disruptions, service provider performance issues), escalating issues to CST and PDT as needed.
•Collaborating with CQRM, CQOM, and CST to develop, maintain, and review the program-level RACT (including program-specific metrics and thresholds, e.g., KRIs, QTLs), and reviewing and approving the Program Quality Plan.
•Reviewing protocol-level CTQ factors and key trial plans to ensure program-/disease-area/asset-level consistency as appropriate and quality control (e.g., reduction of manual data tracking/review efforts, appropriate balance between site & central monitoring).
•Owning proactive inspection readiness across the trial/program lifecycle, including supporting the authoring of post-inspection observation responses and CAPA/SQI management, in close collaboration with Clinical Quality Operations.
•Serving as the operational representative on the Product Development's Clinical Subteam to escalate trial-/program-/disease-area-/asset-level risks, quality issues, and timeline/cost challenges, integrating solutions into program-level planning.
•Collaborating and facilitating interactions with key internal and external stakeholders (e.g., KOLs, vendors) in support of clinical program/disease-area/asset objectives.
•Leading and implementing process improvement and strategic initiatives (e.g., digital transformation).
•Potentially leading operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations).
•Training, upskilling, and supervising direct and indirect reports, and managing the professional development and performance of direct reports, which may include Trial Managers and other Program Leaders.
•Supporting CTT onboarding and developing Trial Manager role-specific training.
•Championing and driving initiatives for digital proficiency/AI fluency to enhance efficiency and data-driven decision-making in clinical operations.
Division/Area: Clinical Development
Job Level/Grade: 500/R6
Reports to: TBD
Location: UG/RY/Other
Extent of Travel: ~15%
Qualifications, Skills & Experience
Core Skills:
•Expert knowledge of GCP and ICH regulations.
•Expert understanding of end-to-end clinical research process, TA, and competitive landscape.
•Drives strategic adoption of scalable digital and AI-enabled approaches; experience in reviewing AI output, understanding limitations and constraints.
•Advanced knowledge of clinical database platforms, central monitoring/RBQM platforms & data review tools.
•Demonstrate advanced delegation, project-management, and program-wide decision-making skills to meet business needs and drive changes that shape the support, resourcing, and implementation of projects, programs, and/or technologies according to a budget/project plan.
•Ability to interact collaboratively and navigate high-stake conflicts with key internal/external stakeholders, leading through deep expertise and strategic influence.
•Demonstrate advanced problem solving, critical thinking, and scenario-planning skills (i.e. resolving complex technical, operational, and financial problems by weighing resource availability against department objectives), keeping an enterprise vision/view.
•Demonstrate advanced verbal and written communication skills.
•Demonstrate strong leadership by influencing internal & external stakeholders, and building talent through oversight, coaching, and mentoring.
Education/Experience:
•Bachelor's degree + 15 years
OR
•Master's + 12 years
OR
•PhD/PharmD + 8 years
Pharmaceutical and/or clinical drug development experience.
Preferred Experience:
•Degree in life sciences, preferred.
•Project Management Professional (PMP) certification preferred.
Required Skills: Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Ethical Standards, Exercises Judgment, Global Clinical Studies, Patient Safety, Regulatory Submissions, Scientific Writing, Therapeutic Knowledge
Preferred Skills: Adaptability, Innovation, Strategic Thinking
Compensation
The primary location for this posting is: USA - New Jersey - Rahway.
The salary range for the primary location of this role is $210,400.00 - $331,100.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
A comprehensive package of benefits is offered, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.
Other Details
•Employee Status: Regular
•Relocation: No relocation
•VISA Sponsorship: No
•Travel Requirements: 10%
•Flexible Work Arrangements: Not Applicable
•Shift: 1st - Day
•Valid Driving License: No
•Hazardous Material(s): No
