Overview
The Senior Clinical Scientist participates in support of the Clinical Development plans (CDPs) and supports the assigned Medical Director/Clinical Science Physician(s) with various deliverables necessary for effective and efficient CS plan execution for the assigned assets/indication(s).
The Senior Clinical Scientist has primary responsibilities for supporting Medical Directors/Clinical Science Physicians with clinical documentation, representing Clinical Science on various teams/sub-teams or other appropriate forums, and supporting training of study site and/or CRO personnel. The Senior Clinical Scientist is expected to perform their responsibilities with independence and are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), and external vendors supporting the work of Clinical Science.
Specific Responsibilities
- Supports the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
- Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
- Supports cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
- Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy and safety data to establish the presence or absence of trends and follow up as appropriate
- Collaborates on, or leads where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
- Supports clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
- Maintains 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.
Education and Qualifications
- MD, PhD, OD, or PharmD with oncology experience required.
- Cell Therapy experience preferred.
- 6+ years of experience in a clinical research-related role. 3-5 years' experience in a Clinical science/development role preferred.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation, data cleaning
- Experience with Spotfire and/or other data capture tools preferred
- Knowledge of melanoma or sarcoma therapies preferred but not required
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Previous experience working with CROs and other vendors/suppliers preferred
- Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
- Data listing review experience required
- Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
- Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, safety, regulatory, commercial operations, etc.
- Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
- Good interpersonal, verbal communication and influencing skills; can influence without authority
- Strong written communication skills
- Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
- Ability to travel (~10%)
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
