Senior Scientist, Clinical Operations – Immunology Full-time

Clinical Trial Scientist

This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross functional team.

Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:

• Serving as the lead clinical scientist on the clinical trial team.
• Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.

Other responsibilities include:

• Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
• Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
• Providing tactical/scientific mentorship to other clinical scientists.

Demonstrated ability to drive and manage scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
• Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
• Interact with key stakeholders across department, division, and company.
• Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Build team capabilities through proactive coaching
• Strong communication, technical writing, and presentation skills

Bachelor's degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR master's degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD degree Degree in life sciences, preferred.

Ideal candidate would have:

• Experience in conducting global clinical trials, including trial initiation through database lock.
• Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology, Rheumatology, or ophthalmology, especially autoimmune or immune-mediated disorders.
• Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria)
• Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
• Managing other scientists directly supporting the clinical trial

Accountability, Adaptability, Clinical Data, Clinical Operations, Clinical Research, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials, Data Analysis, Dermatology, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Parasitology, Prioritization, Regulatory Compliance, Regulatory Documents, Rheumatology, Scientific Publications {+ 2 more}

Salary range for this role is $117,000.00 – $184,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.