Associate Director, Clinical Operations

3 weeks ago

Bedford, United States Progenics Pharmaceutical Inc Full time
Job DescriptionJob Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

The Associate Director, Clinical Operations leads the planning, execution and conduct of complex clinical programs while adhering to budget, scope and timelines. The AD, Clinical Operations is responsible for managing all aspects of multiple clinical trials with emphasis on CRO, vendor and internal team management to drive a high functioning and results- driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.

The role is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing. The incumbent must have a demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, motivate a team and drive results.

Key Responsibilities/ Essential Functions

  • Provide leadership to study teams & make recommendations in strategic aspects of clinical programs
  • Leads the creation of initial study budgets with input from cross functional leads and acts as the primary point of contact with finance and leadership team throughout the life of the study.
  • Establish and continuously monitor/update the global study timelines and budgets, including all internal functional areas, vendors, CROs, and promptly escalating significant risks or changes
  • Serve as primary Operations contact for internal and external study team members on assigned studies/projects and as the escalation point for investigators and sites
  • Lead the selection of CROs, consultants, and vendors including identifying potential vendors and developing proposal requests
  • Oversee CRO and/or vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out
  • Lead cross-functional development of and adherence to study specific operational plans, and processes ensuring clear roles, responsibilities, and communication pathways. Plans and processes may be developed in collaboration with vendors including plans for vendor oversight, project management, communication, recruitment, monitoring, and risk management. These will ensure studies are conducted efficiently, effectively, and in accordance with the protocol, GCP/ICH guidelines, federal regulations, and applicable SOPs.
  • Contribute to development of plans and documents led by other functions such as data management and data review plans, statistical analysis plan, safety management plan, etc
  • Track and report on the overall status of assigned clinical trials including enrollment metrics, key performance indicators (e.g., deviations, trial risks, monitoring metrics), milestones, timelines, and budgets
  • Continuously assess risks to study performance, timelines, budgets and proactively plan risk mitigation strategies
  • Organize and participate in meetings, i.e., Study Team, Trainings, Investigator, and Scientific
  • Review and/or directly contribute to study documents such as vendor specifications, study manuals, training materials, site and patient facing materials, CRFs, monitoring reports, special correspondence, communication plans, etc.
  • Contribute to protocols, clinical study reports, annual reports, key safety reports, and regulatory documents
  • Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc)
  • Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance
  • Review and/or write SOPs for Clinical Operations and Clinical Development, update and maintain SOPs, and participate in departmental improvement initiatives
  • Direct or indirect management and oversight of CTA and/or junior COLs
  • Contribute to management decisions on project team resourcing needs and strategy
  • Perform other duties as assigned

Basic Qualifications

  • Education: Bachelors’ degree in science or nursing
  • Experience: Minimum of 10 years of clinical research experience, with minimum of 6 years trial management experience in industry (sponsor or CRO) At least 5 year of vendor management experience is required. Experience with oncology, neurology and/or radiopharmaceuticals required
  • Preferred: Masters’ degree (MBA, MS or MPH) or PMP certification. Experience with monitoring oversight or direct monitoring preferred.

Other Requirements

  • Possess highly effective interpersonal and analytical skills enabling influencing and negotiation skills
  • Strong problem solving and decision-making skills
  • Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines and applicable regulatory requirements is required
  • Experience in clinical program management, and clinical operations management of clinical trials
  • Well organized and detail oriented with strong written and verbal communication skills
  • Highly proficient in MS Office applications

Core Values:

The ideal candidate will embody Lantheus core values:

  • Let people be their best
  • Respect one another and act as one
  • Learn, adapt, and win
  • Know someone’s health is in our hands
  • Own the solution and make it happen

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