Clinical Scientist, Clinical Development

This is what you will do:

The Clinical Development Scientist (CDS) provides input into a clinical study protocol and supports a clinical study team. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution.

You will be responsible for:

• Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Liaising with other functions to enable quality clinical study execution; Provide input to the study team for country and site feasibility assessments
• Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
• Participating in Investigator meeting planning and execution and/or on-site initiation meetings.
• Monitoring, cleaning, analyzing and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
• Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area.
• Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents. Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
• Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Supporting development of publications arising from studies and other relevant initiatives.
• Providing support for business development activities, such as due diligence and research collaborations.
• Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting related to liquid, tissue and/or imaging endpoints.

You will need to have:

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)
• For Director level at least 3 years of industry experience
• Understanding of general (and specific) therapeutic principles
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• For those assigned to clinical endpoint support, e.g., imaging, experience in at least one meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance, positron emission tomography
• Specific therapeutic area experience
• Basics of strategic vs. tactical thinking
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• 2 years of experience in designing and executing clinical