Utilizing company's clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science (Clinical Science Lead, Immunology) on the Clinical Research and Development team, responsible for leading or supporting the design, data collection and clinical studies, reporting activities that comprise the development and design of a clinical drug program/portfolio, to determine the drug's efficacy, based on the interpretation of trial results.
Serves on the clinical development team, working collaboratively with the Medical Director(s) to develop the clinical development plan for the designated indication. Responsible for the writing of clinical documents, which may include clinical protocols and associated amendments, charters, safety monitoring plans, process documents, scientific manuscripts and abstracts, posters and scientific presentations, briefing documents, IND reports, clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates and the clinical sections of regulatory submissions to support product approvals, etc.
Gathers clinical data ensuring that the clinical development process utilized is aligned with strategic objective(s), as well as regulatory reporting requirements (working with biostatistics and data management). Plan for interim data analyses and reviews. Monitors and evaluates emerging clinical data, reviewing, analyzing and interpreting study data, presenting study-related scientific and medical data as a basis for the development and design of the clinical drug program or portfolio.
Selects and develops the clinical outcome measure, completing the data review, and undertaking the subsequent clinical trial activities.
Select/liaise with extramural consultants (i.e. Data Safety Monitoring Board and Steering Committees).
Reviews and interprets data, producing abstracts, presentations and manuscripts.
Contribute to development of the clinical protocol by performing medical literature and new technology reviews, seeking input from various R&D functions.
Collaborates with the Medical Director(s), clinical operations, and other R&D organizations to conduct clinical review of the study data; reviewing and discussing the clinical study reporting documentation, and as the studies end, securing the data and completing the study reporting.
Collaborates with other functions to: develop and implement the overall data quality plan; to review safety narratives and other safety-related guidelines and documentation, while tracking, analyzing, and reporting any potential safety events.
May serve as the study point-of-contact regarding questions associated with an assigned study (ies) or program(s) coming from internal functions, such as clinical operations, or externally from a CRO.
Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform, so as to develop a current understanding and outlook regarding internal and/or external influences, and their implication on Immunology studies.
Requirements / Qualifications:
This position requires a Bachelor's degree, in the Life Sciences, or the equivalent. An advanced scientific degree (e.g., Master's Degree in Science, a PhD or PharmD) is preferred. Possessing a strong scientific background in the therapeutic area of Immunology. Additional expertise in Gastroenterology, Dermatology, Allergy, and Rheumatology preferred.
Possesses a strong scientific background, having five to seven years pharmaceutical industry experience in clinical drug development and the associated regulatory processes. Has extensive knowledge in clinical research, understanding the design and management of clinical trials. Previous experience across Phase I-III drug development projects is required, with a focus on Immunology product development. Academic drug development experience will be considered.
Demonstrated understanding of and the experience supporting clinical trial design, having been responsible for developing essential documents (such clinical trial protocols, protocol amendments, case report forms, etc.), along with the driving the execution of the clinical study(s).
Project planning skills, focusing on realistic, efficient, and effective plans.
Utilizing attention to detail, and strong organizational skills, has established a successful track record managing the clinical strategy and the associated study(s), ensuring the necessary data collection documentation is accomplished for the required analysis and interpretation of clinical trial results.
Possesses technical expertise and knowledge of Immunology, specifically the drug compound and the emergence of new technologies and advancements in the care of the patient and treatment of Autoimmune diseases, so as to have the credibility to serve as a liaison with internal/external partners (clinical investigators, key opinion leaders (KOLs), medical directors, etc.).
Subject matter expert with a strong analytic background, and compelling written and verbal communication skills, capable of presenting clinical data and complex findings to team members and members of senior management/decision makers, as well as external audiences and/or experts.
Recognizing the value of working cross-functionally, demonstrated ability to operate collaboratively to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives, maintaining an awareness of regulatory requirements, as well as commercial objectives.
Knowledge of regulatory guidelines and standards (GCP, ICH and regulatory agency (FDA) guidelines).
Possesses ability to author scientific documents, including documentation supporting regulatory submissions.
High performing and able to work independently, organizing priorities and managing project timelines, while possessing the necessary interpersonal skills and strong analytical skills that enable the successful team collaboration so as to accomplish clinical strategy.
Ability to read printed materials and written information on a computer screen is required.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
As a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.
This role requires the incumbent to travel based upon the needs of the business, up to 30% of the time.