Senior Director, Clinical Science

Overview

The Senior Director, Clinical Science participates in development of the Clinical Development plans (CDPs) and supports the assigned Medical Director/Clinical Science Physician(s) with various deliverables necessary for effective and efficient CDP and clinical trial execution for the assigned assets/indication(s).

The Senior Director, Clinical Science 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, supporting training and interactions with study site personnel. The Senior Director, 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), and external vendors supporting the work of Clinical Science.

Essential Functions and Responsibilities

Cross-Functional Team Membership:

• Participates in the relevant cross functional team meetings as needed. Interface with Data Management, Clinical Operations, Biostatistics, Biomarkers, Business Development, Legal, Logistics/Manufacturing Operations, 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 with training Iovance SMT and Clinical site personal such as protocol amendment.
  
  

Global Clinical Development Planning:

• 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)
• Contributes to the development of the Clinical Study Protocol for relevant assets(s)/indication(s)
• Gathers and analyzes data and information necessary to create the CDP

Clinical Development Plan Implementation:

• Provides clinical science support for assigned studies and programs
• Participates in ongoing cross functional meetings, other interactions and communications as needed
• Designs and contributes to writing of 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.
• Writes and/or reviews additional clinical science documentation and/or provides clinical science input into other documentation managed by other Iovance groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
• As needed/appropriate, collaborates with others in the review of patient narratives, 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 support with site training, as needed
• Support Clinical Science team in clinical review of study data
• Reviews, analyzes and discusses clinical study reporting documents with CS Medical Directors/Clinical Science Physicians and various other groups
• 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, contributes to and/or reviews abstracts, posters, content for scientific meetings, conferences, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Conducts appropriate literature searches
• If needed, 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
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge 

• 12+ years’ clinical trial experience with relevant therapeutic area experience
• Data table figure listing review experience is mandatory
• Experience with authoring clinical study protocols and summarizing 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, literature and clinical trial data
• 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; Team player 

Preferred Education, Skills, and Knowledge

• Advanced Clinical/Science Degree is preferred (e.g., PhD, PharmD, MD)
• Clinical and basic science research in immunotherapy / tumor immunology preferred 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

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 or remote office environment and requires operating standard office equipment and keyboards. 

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.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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