Overview
The Director, Clinical Science participates in development of the Clinical Development plans (CDPs) and supports the assigned Medical Director/Clinical Science Physician(s) and Head of Clinical Science with various deliverables necessary for effective and efficient CS plan execution for the assigned assets/indication(s).
The Director Clinical Science has primary responsibilities for supporting Medical Directors/Clinical Science Physicians and Head of Clinical Science with clinical documentation, representing Clinical Science on various teams/sub-teams or other appropriate forums, supporting training of study site personnel. The Director of Clinical Science is expected to perform their responsibilities with more independence and are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of Clinical Science
Specific Responsibilities
Cross-Functional Team Membership
- Participates in the relevant Clinical Development Core Team (CSCT) and Clinical Sub-Team (CST) meetings as needed. Interface with Biomarkers, Biometrics, Business Development, Clinical Operations, Legal, Logistics/Manufacturing Operations, PK/PD, Process Development, Project Management, Quality Assurance, Regulatory Affairs, Translational Medicine, and other members of the extended project team(s).
- Represents Clinical Science (CS) in operational meetings (e.g., Study Management Team [SMT] meetings) as needed.
- As requested, supports CS Medical Directors/Clinical Science Physicians and Head of Clinical Science with training new CSCT members
Global Clinical Development Planning
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CS to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the relevant therapeutic and disease area(s)
- Maintains scientific and clinical knowledge in the relevant therapeutic and disease area(s)
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including translational research, business development, manufacturing/clinical supply chain operations, legal, etc.
- Supports CS Medical Directors/Clinical Science Physicians, as assigned, in developing and/or preparing clinical science information for inclusion into the CS strategy for the relevant therapeutic/disease area(s), annual and strategic Lifecycle Plans (LCPs) and the integrated commercialization plan
- Contributes to the development of the CTP for relevant assets(s)/indication(s)
- Gathers and analyzes data and information necessary to create the CS plan
Clinical Development Plan Implementation
- Provides clinical science support for assigned studies and programs
- Conducts appropriate literature searches
- Participates in ongoing CDCT, CST and SMT meetings, other interactions and communications as needed
- Provides input on clinical study designs.
- Designs clinical protocols, manuals and forms with guidance and oversight from CS Medical Directors/Clinical Science Physicians
- Collaborates with clinical operations, other groups and CS MD Directors/Clinical Science Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Iovance teams and projects (includes partner studies)
- Writes and/or reviews additional clinical science documentation and/or clinical science input into other documentation managed by other Iovance groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
- Helps coordinate the successful completion of documents across other groups
- As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
- May develop or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with CS Medical Directors/Clinical Science Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
- Provides additional support with site training, as needed, or requested
- Support Clinical Science team in clinical review of study data as needed.;
- Reviews, analyzes and discusses clinical study reporting documents with CS Medical Directors/Clinical Science Physicians and various other groups
- Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
- Supports CS Medical Directors/Clinical Science Physicians in preparing for internal/external meetings and presentations
- Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders.
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- I directed, supports CS Medical Directors/Clinical Science Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation.
- If needed, writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- Completes and/or leads other special projects, as and when assigned, or otherwise requested
- Consistently complies with all governing laws, regulations, Iovance Standard Operating Procedures (SOPs) and other guidelines
Education and Qualifications
- Advanced Clinical/Science Degree is preferred (e.g., PhD, PharmD, MD)
- 7+ years’ clinical trial experience with relevant therapeutic area experience
- 2+ years’ experience in clinical science
- Clinical and basic science research in tumor immunology preferred
- Data listing review experience is mandatory
- Experience authoring experimental protocols and/or study results and conclusions
- In-depth understanding of Phase 1 through 4 drug development
- 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.)
- Comprehensive understanding of product and safety profiles
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- 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, 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 (~25%)
Physical Requirements
- Sit for an extended time in front of a computer
#LI-remote
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
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