Associate Director, Global Trial Optimization
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Activities:Provides vision, leadership, oversight, mentoring and coaching of Global Trial Optimization Specialists(GTOS) in producing GTO deliverables. Serves as process owner for assigned processes and is responsible for driving continuous improvement of assigned processes, functions and deliverables within GTO. (30%)
Manages resources to ensure business needs are appropriately supported and workload is balanced. Recruits, hires, manages, mentors, and provides feedback and development opportunities for direct reports, ensuring skill growth and compliance to relevant policy and procedures. (15%)
Provides oversight to assigned GTO functions or Therapeutic Area(s) for program and protocol timeline planning activities, feasibility assessment and recruitment and retention support. Collaborates closely with CSSM Program leads, GPAM CST leads TA-Clinical Directors and regional GCTO colleagues in aligning MRL teams with senior management. (20%)
Manages and adheres to departmental budget as it relates to resources assigned within function/TA. Collaborates to establish performance metrics for his/her teams and monitors these metrics in an effort to continually enhance capabilities and improve overall quality of deliverables. (5%).Represents GTO on program-level operations teams, leading the development of feasibility input to programs, timeline projection and program-level Recruitment and Retention strategies. Oversees and develops junior GTO staff in execution of CTT level contributions. (30%)
Impact:Oversees and actively participates in portfolio planning activities related to overall operational planning of regional participation, timelines and study recruitment needs which enable predictability of PA - LPE timelines and study enrollment.
Decision Making:Actively spearheads process improvement initiatives based on objective observations and key performance indicators. Is empowered to take action through sponsorship from GTO, GO, and GCTO senior management.
Problem Solving:Leads and supports the GTOS' in trouble shooting issues, root cause analyses and adjustments to feasibility methodology or retention/recruitment planning. Analyzes and identifies trends, adaptations, best practices, potential problems, and opportunities for process improvement.
Expertise:Should possess excellent interpersonal communication skills and people management experience. Should have experience in the conduct of clinical trials and knowledge in business process analytics, management and continuous improvement. Should demonstrate administrative and project management skills in a leading position.Leadership:Models Merck leadership standards in advocating and enabling collaborative work between members within GTO and stakeholders. He/she will be a key contributor to the GTO's interactions with CSSM Program and/or TA leads and their teams, Clinical TA leadership and governance committees, and relevant franchises, and will have responsibility for Recruitment and Retention budgets in assigned TA(s).
Influence / Liaison:Must have ability to think strategically and lead effectively in a virtual, culturally diverse environment. Identifies opportunities, and fosters collaboration and partnership within the organization (CSSM, GPAM, GCDRA, MRL). He/she will drive Indication or function-specific strategy in interactions with external vendors, such as: clinical research organizations, investigator networks, site management organizations, hospital or university clinical research units, advocacy groups, and recruitment vendors.
- Bachelor or Master of Science degree in medical/pharmaceutical/biological sciences
- At least 10 years of career experience including minimum of 5 years’ experience in the conduct of clinical trials and expertise in business process analytics and continuous improvement.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Research - Clin Ops
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck