Clinical Development Scientist, Clinical Program Lead

About the role

The Clinical Development Scientist will be a key member of the Clinical Development team and will partner with cross-functional teams in the design and execution of clinical studies. They will support the Senior Director of Clinical Development – Ophthalmology with efficient execution of deliverables by supporting the planning, conduct, analysis and reporting of clinical studies across various therapeutic areas within ophthalmology. They will work independently under the guidance of the Senior Director of Clinical Development Ophthalmology and in collaboration with relevant internal stakeholders to achieve corporate objectives with a focus on upholding quality, integrity, and leveraging strong cross-functional partnerships while complying with company SOPs. They will work closely and effectively with Clinical Operations and other members of the study team in the overall conduct and timely execution of clinical trials. Internally, they will support and manage preparation of clinical study documents, perform medical monitoring, attend SIVs, prepare content for advisory boards, and enthusiastically support cross-functional partners as relevant. Externally, they will work with vendors, consultants, and SMEs for clinical development related activities such as organizing and attending advisory boards, roundtables, and document preparation and submission. 10–20% travel may be expected both globally and domestically.

Responsibilities

• Assist the clinical development lead in the preparation of clinical study-related documents (potentially several studies in parallel) including protocols, investigator’s brochures, clinical study reports, case report forms, informed consent forms, and meeting presentations in compliance with company SOPs where applicable.
• Coordinate with internal stakeholders (e.g., operations, regulatory, biostatistics, pharmacology/toxicology, QA) to facilitate efficient execution of clinical studies.
• Assist in the implementation of protocols and interactions with vendors and CROs, engaging with relevant external stakeholders.
• Perform medical monitoring under the guidance of the Senior Director of Clinical Development – Ophthalmology and in close partnership with Clinical Operations and Safety/Pharmacovigilance.
• Support Data Management in the building of CRFs for clinical studies.
• Prepare presentations for meetings such as scientific advisory boards, investigator meetings, and internal study progress updates.
• Assist in the preparation and/or review of posters or presentations for external presentation.
• Assist in the development of clinical trial data collection in the EDC system and Case Report Forms.
• Perform literature searches for clinical development activities and other relevant scientific information with the ability to distill key information.
• Work independently, responsibly, and collaboratively as part of a lean matrix environment.
• Demonstrate flexibility to meet deadlines and to respond to frequent and/or unexpected changes.
• Manage external vendors supporting clinical development activities, providing clear direction and ensuring timely completion of key deliverables.
• Keep abreast of therapeutic-area landscape with respect to treatment paradigms, preclinical advancements, and competitive intelligence.

Qualifications

• Life sciences degree or equivalent with 4 years’ research experience in academic, hospital, CRO, or industry setting; ophthalmology experience preferred.
• An advanced degree in life sciences (MD, OD, PhD, MS, RN, PharmD or equivalent) is preferred but not required.
• Clinical drug development experience is preferred but not required.
• General knowledge of the principles of clinical research methodology (medical monitoring) and regulations (GCP).
• Strong familiarity with scientific literature searches and using reference managers.
• Strong familiarity with Microsoft Office (Word, PowerPoint, Excel).
• Excellent spoken and written English with strong communication skills.
• Ability to use a computer, engage in communications via phone, video, and electronic messaging, collaborate with others, and ensure availability as needed to ensure timelines are met.
• Ability to understand, interpret, and communicate clinical information including literature reviews, competitive intelligence, and changing treatment guidelines in order to apply knowledge to support a robust overall clinical development strategy.
• Critical traits for success include strong organizational and time management skills, attention to detail, agility and resourcefulness in problem solving, proactive thinking, can-do attitude, desire to learn and grow, communicating regularly with line manager, and leveraging strong relationships with cross-functional team members.
• Ability to work independently and to organize priorities to meet deliverables.
• Highly self-motivated, flexible, and comfortable with broad responsibilities in an entrepreneurial, fast-paced, high-demand, and dynamic matrix environment where there may be multiple demands due to changes in tactics or priorities.

Preferred experience, knowledge, and skills

• Minimum 4 years’ clinical research experience in the pharmaceutical industry, CRO, or academic institution.
• Published in peer-reviewed journals.

Benefits of joining our team

• Comprehensive medical benefits.
• Generous vacation and holiday time off.
• Competitive 401(k) matching.

Pay

$161,000 – $189,000; actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Incentive bonus and benefits package customary to the position are included.