Associate Director, Clinical Site Liaison

4 days ago

New York, United States argenx Full time

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Associate Director, Clinical Site Liaison (CSL) is a field-based expert who supports the conduct and the patient recruitment of argenx global clinical trials at investigative sites, through local and relational support.

The successful candidate will have clinical trial operational experience and deep understanding of patient pathways and trial recruitment. Proven expertise in engaging, building and maintaining excellent working relationships with country/region specific investigative sites, KOLs, site networks and Patient Advocacy groups (PAG). From within the Trial Operations (Trial Ops) team, closely work together with the clinical trial/ indication teams and with CROs and other vendors. Collaborate with the argenx Global Patient Advocacy (GPA) group, as well as, with the Medical Affairs group (MSLs).

Roles and Responsibilities:

  • Participate in neurology franchise and study-level feasibility activities through providing key country/ regional and site-specific knowledge including patient pathways and operational execution
  • Interface and act as a local argenx TrialOps representative, an expert on the clinical trial protocol(s) and SME providing the sites with knowledge and awareness about the current and upcoming clinical trials
  • Lead and engage in local site, KOL and network engagement initiatives in view of the clinical trials
  • Contribute to the trial specific site feasibility / selection strategy and collaborate with the Clinical Trial Team (CTT) and CRO to support the site start-up process as needed
  • Facilitate with the site contract negotiation/signature as needed, collaborate with the GloSaM group
  • Proactively work to fully understand all matters that impact the successful patient recruitment and high-quality conduct of the clinical trial at each site, eg the Principal Investigator (PI) and site preferences and best practices on clinical trials, standard of care treatments, competing studies etc. Ensure a supportive relationship with clinical sites and trial personnel
  • Proactively work to fully understand the patient voice, preferences and pathway(s). Closely work with the argenx GPA team. Speak to patient groups and support groups, live events and conferences as allowed by local / regional guidance. May also attend live and virtual patient events to assist in responding to questions about argenx, the trial(s) and other information on Mode of Action (MOA)
  • May participate in monitoring oversight activities such as accompanying the CRO CRA during site visits. This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements
  • Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support
  • Optimize site engagement for a specific trial and across the neurology franchise to ensure site engagement and quality for the site-level enrollment and execution of every trial
  • Oversee and track patient recruitment for the regional sites and pro-actively identify ways to prevent recruitment delays
  • Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the respective study CTM, CODL, Global Head of Clinical Site Communication, Recruitment and Liaisons, Head of Trial Operations and/or Senior Management, as needed
  • Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications/compounds
  • Search for and embrace innovation
  • May be asked to provide input to the clinical development strategy/plan
  • Participate in workstreams and provide input to procedures/SOPs/WIs and related documents

Skills and Competencies:

  • Knowledge of ICH-GCP and other applicable legislation
  • Ability to quickly understand complex neurological disease areas, treatments and clinical development plans
  • Understand the healthcare therapeutic landscape, patient pathways and investigative sites
  • Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, networks, PAGs, CROs and others
  • Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority
  • Highly developed organizational skills, problem solving, analytic and able to prioritize
  • Experience with tools and systems for managing clinical studies

Education, Experience and Qualifications:

  • Bachelor's degree, Scientific or health related field University degree - medical or para-medical (MD, Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 6 years of experience in Biotech / pharma preferably in roles including site engagement and / or clinical trial monitoring experience
  • Valid driver's license
  • Ability for travel nationally and occasional international travel.
  • Experience in global clinical trials is a plus
  • Prior experience in Neurology, Auto-immune and rare disease background

#LI-Remote

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

PDN-9caa9d24-1436-48e6-a591-c856845aa1b3

  • Site Director

    3 weeks ago

    New York, United States Cherokee Federal Full time

    Site Director Please Note: This position is pending a contract award. If you are interested in a future with Cherokee Federal, APPLY TODAY! Although this is not an approved position, we are accepting applications for this future and anticipated need. The Site Director will oversee the entire Case Work operation and will serve as the main liaison with the New...

  • Clinical Scientist

    1 month ago

    New York, United States Masis Professional Group Full time

    Clinical Scientist & Liaison Manager (Hybrid in NYC)Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with extensive clinical science experience to join their dynamic clinical development team.Company offers a very generous compensation & benefits package.MUST HAVES:Strong Scientific Background: A solid scientific...

  • Site Medical Director, Correctional Health Services, OTxHU

    3 months ago

    New York, United States NYC Health + Hospitals Full time

    New York City Health and Hospitals CorporationOutposted Therapeutic Housing Units Program (OTxHU)Since 2016, Correctional Health Services (CHS) has been the direct provider of health care in the New York City jails. Deeply committed to human dignity and patient rights, CHS is part of the NYC Health + Hospitals system and is a key partner in the City’s...

  • Site Director

    4 weeks ago

    New York, New York, United States The Dorm LCSW PLLC Full time

    Job DescriptionAt The Dorm LCSW PLLC, we are seeking a highly skilled and experienced Site Director to lead our multidisciplinary team in providing comprehensive, evidence-based treatment to young adults. As a senior leader, you will be responsible for ensuring the implementation of our therapeutic care model daily, managing and leading the clinical team,...

  • Clinical Liaison RN Position in New York

    4 weeks ago

    New York, New York, United States Talent4Health Full time

    Talent4Health is seeking a skilled Clinical Liaison RN to join their team in New York.Job DetailsSpecialty: Clinical LiaisonDiscipline: RNEmployment Type: Local ContractThe ideal candidate will have experience in infusion and/or home health, with the ability to cover multiple sites and travel to various hospitals as needed.About the RoleAs a Clinical Liaison...

  • Clinical Scientist

    1 month ago

    new york city, United States Masis Professional Group Full time

    Clinical Scientist & Liaison Manager (Hybrid in NYC)Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with extensive clinical science experience to join their dynamic clinical development team.Company offers a very generous compensation & benefits package.MUST HAVES:Strong Scientific Background: A solid scientific...

  • Clinical Scientist

    1 month ago

    new york city, United States Masis Professional Group Full time

    Clinical Scientist & Liaison Manager (Hybrid in NYC)Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with extensive clinical science experience to join their dynamic clinical development team.Company offers a very generous compensation & benefits package.MUST HAVES:Strong Scientific Background: A solid scientific...

  • Director, Site Engagement

    2 months ago

    New York, United States Piper Companies Full time

    Piper Companies is looking for a Director, Site Engagement to join a leading specialty care company for an onsite/travel-based role based in the NJ/NY/CT/PA areas. The Director, Site Engagement will be responsible for traveling approximately 75% of the time to support in full revenue cycles.Responsibilities for the Director, Site Engagement:·Act as Revenue...

  • Clinical Services Director

    4 weeks ago

    New York, New York, United States HSS Full time

    Clinical Services Director Job DescriptionAt HSS, we are seeking a highly skilled Clinical Services Director to join our team. This role is responsible for facilitating excellence in patient care delivery, improving operational efficiency, and ensuring compliance with hospital and regulatory policies and practices at our ambulatory locations.The ideal...

  • Director of Clinical Operations

    3 weeks ago

    New York, United States CareAbout Full time

    New York, New York 10036 Company Description CareAbout Health is a managed services organization (MSO) that provides expert advice, resources, tools, and other support to its portfolio of medical groups and healthcare focused companies. CareAbout Health is helping align incentives to create a world where patients, providers, and payers work together in a...

  • Clinical Services Director

    4 weeks ago

    New York, New York, United States HSS Full time

    Clinical Services Director Job DescriptionOverviewHSS is seeking a highly skilled Clinical Services Director to join our team. As a key member of our leadership team, you will be responsible for facilitating excellence in patient care delivery, improving operational efficiency, and ensuring compliance with hospital and regulatory policies and practices at...

  • Associate Medical Director

    2 weeks ago

    New York, United States Physician Affiliate Group of New York, P.C. (PAGNY) Full time

    Physician Affiliate Group of New York (PAGNY) is seeking Associate Medical Directors to oversee community-based health practices at NYC Health + Hospitals/Gotham Health, the largest public health care system in the country. We are currently accepting applications for an Associate Medical Director overseeing Gotham Health Neighborhood Health Clinics in...

  • Bilingual On-Site Office Liaison

    2 weeks ago

    New York, New York, United States Aerotek Full time

    **Job Summary:**The On-Site Construction Office Associate plays a pivotal role in providing exceptional administrative and customer support services to clients and the Onsite Management team.Key responsibilities include ensuring timely screening of contract employees, facilitating site orientation processes, and fostering a professional work environment that...

  • Associate Director of Strategic Partnerships

    1 week ago

    New York, United States EPIP Full time

    Associate Director of Strategic Partnerships (CCI) Posted on September 26, 2017 The Center for Court Innovation, a project of the Fund for the City of New York, is a non-profit organization that promotes new thinking about how to reduce crime and incarceration while strengthening public trust in justice. The Center creates operating projects, including the...

  • Clinical Deputy Director, Correctional Health Services

    6 months ago

    New York, United States NYC Health + HospitalsCorrectional Health Services Full time

    NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers...

  • Clinical Director

    3 weeks ago

    New York, United States Pfizer Full time

    ROLE SUMMARY The Clinical Lead (CL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of metabolic diseases at Pfizer. S/he will be responsible for creating the overarching strategy for early clinical development programs with a focus on innovative design, medical and scientific excellence, and the...

  • CBO Liaison, Bureau of Public Health Clinics

    3 months ago

    New York, United States City of New York Full time

    Company DescriptionJob Description Division/Program Summary Description: The Bureau of Public Health Clinics (BPHC) has the mission of improving the sexual heath of all New Yorkers. To achieve this the Bureau provides direct clinic services to people seeking sexual health care and services for their sex partners. The BPHC operates 8 sexual health clinics...

  • CBO Liaison, Bureau of Public Health Clinics

    3 months ago

    New York, United States City of New York Full time

    Job Description Division/Program Summary Description: The Bureau of Public Health Clinics (BPHC) has the mission of improving the sexual heath of all New Yorkers. To achieve this the Bureau provides direct clinic services to people seeking sexual health care and services for their sex partners. The BPHC operates 8 sexual health clinics throughout New York...

  • Clinical Research Associate I

    4 days ago

    New York, United States Mount Sinai Health System Full time

    Job DescriptionThe Clinical Research Associate is an integral part of the research study team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of...

  • Director of Operations and Logistics

    1 month ago

    New York, New York, United States Insight Global Full time

    Job Title: Director of Operations and LogisticsA Federal client is seeking a highly skilled Director of Operations and Logistics to join their team in New York City. The Director will oversee the leases, act as building management liaison, and provide property oversight to ensure overall safety, cleanliness, and presentation of the offices.The ideal...