Lantheus
Associate Director, Clinical Operations
Lantheus, Bedford, Massachusetts, us, 01730
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
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
#LI-HYBRID
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) #J-18808-Ljbffr
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
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
#LI-HYBRID
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) #J-18808-Ljbffr