Clinical Research Scientist

Clinical Research Scientist Medical Affairs (Rheumatology, United States)

Through the application of scientific and clinical training and expertise in rheumatology, the Clinical Research Scientist (CRS) is an integral member of the U.S. Medical Affairs organization, supporting strategic planning and execution of medical activities across the product lifecycle to meet patients' needs and enhance the experience of customerspatients, providers, and payersin the United States.

The CRS contributes to the development and execution of U.S. and global clinical and medical plans in rheumatologic diseases, including autoimmune and inflammatory conditions, and supports launch and commercialization activities. The CRS works closely with global Development teams, Therapeutic Area Program Phase, Early Phase Clinical Pharmacology, Translational Medicine, and other cross-functional partners across the full spectrum of drug development and clinical trial phases.

The CRS ensures that activities are aligned with U.S. Medical Affairs strategic priorities and are conducted in compliance with applicable regulations, laws, guidance (e.g., FDA, ICH), Good Clinical Practices (GCPs), and company policies and procedures, while serving as a scientific resource for study teams and internal stakeholders.

Primary Responsibilities

• Provide expert scientific and clinical support to U.S. business activities across rheumatology.
• Understand and anticipate the scientific information needs of U.S. customers (patients, providers, and payers).
• Contribute to development of medical strategies supporting commercialization activities in collaboration with global Medical Affairs, Global Patient Outcomes/Real World Evidence, PRA, and cross-functional teams.
• Contribute to pricing, reimbursement, and access activities by providing clinical input and supporting interactions with government and payer stakeholders.
• Participate in defining the patient journey and acting as a patient advocate within the rheumatology therapeutic area.
• Support training of sales representatives and other medical personnel.

• Ensure knowledge of and compliance with U.S. regulations, global policies, and procedures governing scientific exchange and data dissemination.
• Support development, review, and dissemination of scientific materials, including abstracts, posters, manuscripts, and educational content.
• Establish and maintain collaborations and relationships with external scientific experts, thought leaders, and the medical community in rheumatology.
• Support planning and execution of symposia, advisory boards, and other scientific interactions with health care professionals.
• Provide congress support, including presentations, medical booth staffing, and engagement with external stakeholders.

• Collaborate with Medical Affairs leadership and global teams to ensure clinical and medical plans address U.S. rheumatology customer needs.
• Communicate U.S. research needs and insights to global Medical Affairs, Development, and Patient Outcomes teams.
• Represent U.S. clinical needs in the development of clinical strategies, development plans, and study protocols.
• Maintain up-to-date knowledge of pre-clinical and clinical data relevant to rheumatology assets.

• Collaborate in the design, conduct, and reporting of clinical trials, including Phase IIV and non-interventional studies conducted in the U.S.
• Participate in investigator identification and selection and serve as a scientific resource to investigators and study teams.
• Ensure compliance with Good Clinical Practices, regulatory requirements, and ethical standards.
• Monitor patient safety and ensure appropriate tracking and follow-up of adverse events in alignment with corporate patient safety policies.

• Provide clinical expertise for U.S. regulatory activities, including labeling, submissions, and interactions with regulatory agencies.
• Support preparation of regulatory documents and participation in advisory committees as appropriate.
• Participate in risk management planning in collaboration with global Development and Global Patient Safety teams.

• Maintain awareness of current trends and projections in rheumatology clinical practice and access.
• Critically evaluate scientific literature and remain informed on competitive landscape and emerging therapies.
• Serve as a scientific consultant and protocol expert within Medical Affairs and cross-functional teams.

• Align activities with Medical Affairs priorities and organizational objectives.
• Collaborate proactively with internal teams and external partners.
• Contribute to coaching, development, and team effectiveness.
• Model leadership behaviors and act as an ambassador of patients and the organization.

Minimum Qualifications:

• Advanced health/medical/scientific degree (PharmD, PhD, MSN with clinical specialty)
• Minimum 3 years' experience in any of the following: clinical, pharmaceutical, clinical development, research.

Preferred Qualifications:

• 5 years' experience within rheumatology, immunology, or closely related therapeutic areas, with exposure to clinical research or Medical Affairs activities.
• Demonstrated understanding of the drug development lifecycle
• Proven experience and strong working knowledge of U.S.-based clinical and/or Medical Affairs activities, including familiarity with applicable regulatory and compliance frameworks.
• Demonstrated scientific expertise, communication skills, and ability to collaborate and influence cross-functional teams.
• Ability to travel as required to support business needs