Senior Clinical Scientist

Employer
CSL Behring
Location
Cambridge, Massachusetts
Posted
Sep 26, 2020
Ref
R-119134
Required Education
Doctorate/PHD/MD
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The position holder has global scientific responsibility for a part of a clinical program. The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Responsibility for, and contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, Investigator's Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications. The Senior Clinical Scientist operates with supervision and review of the Principal Clinical Scientist, Clinical Program Director and/or Therapeutic Area Head, but is the authorized representative of the Therapeutic Area on cross-functional operational teams for the conduct of clinical research. The position holder is responsible for the scientific development of individual clinical studies in alignment with the approved clinical development plan. Responsibilities includes Authorship/ review of clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program. Responsible for the clinical oversight and medical guidance during the conduct of the study, in collaboration with the Principal Clinical Scientist and (Senior) Global Clinical Program Director. Reviews clinical data and contributes to the development of clinical presentations and integration of analyses into clinical documents. Independently review study subject level data, and present relevant issues to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the Benefit-Risk Physician to support ongoing aggregate safety data review during a given clinical study. Liaises with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators. Work closely with the Clinical Operations, and Pharmacovigilance functions to ensure the translation of the protocol and clinical development plans into executable operational processes. Lead internal or external training as required and support the medical monitor in responses to investigators and other site personnel regarding clinical and study conduct questions. Assure that each clinical study is globally coherent, and is consistent with the global clinical development plan, including consideration of functions beyond Clinical Development, such as Medical Affairs, Commercial and Technical Operations. Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, Ad Boards etc.). May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. May participate in and present at these meetings, as required. Manages the processes required to support external study review committees; e.g steering committees. Participates in analysing and interpreting final data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review meetings to determine strategic interpretation. May participate in the company publication group. Serves as a scientific reviewer for company publications and external research proposals in the area(s) of expertise. Participates in the Clinical Operations and Clinical Development teams. Provide support to the clinical development team (CDT) through meeting management support and communication. Act as the delegate for the CDT lead where required. Manages the contractual and budget requirements for clinical strategy needs across programs including but not limited to consultants, data monitoring committees or adjudication boards. Interacts with internal auditing groups on a study level to ensure clinical development activities are conducted according to internal SOPs and work practices and in compliance with ICH-GCP.

The Senior Clinical Scientist has global scientific responsibility for a part of a clinical program. Responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Responsibility for, and contribution to the scientific content of clinical program documents is a key deliverable and includes study

synopses and protocols, Investigator's Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications. The Senior Clinical Scientist operates with supervision and review of the Principal Clinical

Scientist, Clinical Program Director and/or Therapeutic Area Head, but is the authorized

representative of the Therapeutic Area on cross-functional operational teams for the conduct of clinical research.

The position holder is responsible for the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific

content/ rigor is consistent and of the highest quality across the clinical development

program.

Responsibilities include: -

Primarily responsible for the clinical oversight and medical guidance during the conduct of the study, in collaboration with the Principal Clinical Scientist and (Senior) Global Clinical Program Director.

Reviews clinical data and contributes to the development of clinical presentations and

integration of analyses into clinical documents. Independently review study subject level data, and present relevant issues to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the Benefit-Risk Physician to support ongoing

aggregate safety data review during a given clinical study.

Liaise with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators. Work closely with the Clinical

Operations, and Pharmacovigilance functions to ensure the translation of the protocol and clinical development plans into executable operational processes. Lead internal or external training as required and support the medical monitor in responses to investigators and

other site personnel regarding clinical and study conduct questions. Assure that each clinical study is globally coherent, and is consistent with the global clinical development plan,

including consideration of functions beyond Clinical Development, such as Medical Affairs, Commercial and Technical Operations.

May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. May participate in and

present at these meetings, as required. Manages the processes required to support external study review committees; e.g. steering committees.

Participates in analysing and interpreting final data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review

meetings to determine strategic interpretation. May participate in the company publication group. Additionally, serve as a scientific reviewer for company publications and external

research proposals in the area(s) of expertise

Qualifications and Experience: -

Advanced degree (MD, PhD or PharmD) in life science/healthcare required --

Proven experience within clinical research.

Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.

Strong research skills, knowledge of scientific analysis, data mining, and basic statistical

analysis principles required.

Experience in analysing and presenting research results to scientific and professional

audiences.

Experience working in a cross-functional, matrix environment. Exposure to global

multi-cultural teams is desirable.

Experience with the operational aspects of clinical trials and related activities such as

investigator meetings, DSMB's, and GCP/ICH are necessary.

Excellent communication and presentation skills required. Experience in medical/regulatory writing preferable.

Good understanding of drug development process, strong knowledge of ICH/GCP.

Ability to work successfully in a matrix organization and across multiple disciplines, including clinical, regulatory, pre-clinical, product development and commercial management.

Proven networking skills and ability to share knowledge and experience among colleagues.