The position holder is responsible for both scientific input to clinical development strategies for early pipeline projects, acting as a liaison between Research, clinical Development Therapeutic Area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes the Early Development Plan, study synopses and protocols, Investigator’s Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications
Main Responsibilities and Accountabilities
1 Contribute, in collaboration with Research, the scientific rationale for clinical development strategies for early pipeline programs. Develop in-depth understanding of the scientific/clinical development context of a therapy area, perform background research and literature analysis, review and evaluation of clinical data in the generation of study concepts and protocols in the relevant therapeutic area and critical review of scientific developments and the competitive environment to lead a proactive and ongoing strategic re-evaluation of the program(s)..
2 Participate in or possibly lead a matrixed clinical development team, responsible for the generation and maintenance of an innovative, efficient and scientifically sound clinical development plan. May act as the primary representative of ECD on core project teams.
3 Work closely with Research, Global Clinical Operations, Clinical Development, Regulatory and Global Clinical Safety and Pharmacovigilance (GCSP) 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.
4 Independently review study subject level data for presentation to the Scientific Director, GCEDL or GCTP for clinical decision making, throughout the study life cycle. Liaises closely with the clinical safety scientist to support ongoing aggregate safety data review during a given clinical study.
5 May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. May support the scientific and clinical development content of investigator meetings and advisory boards. Support the CSLB “Sponsor of Choice” initiative as it pertains to the ECD programs.
6 Participate in analyzing and interpreting 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 become a member of the company publication group. Additionally serve as a scientific reviewer for company publications and external research proposals in the area(s) of expertise.
7 Participate in the Study Execution Team and Clinical Development teams. Provide support to or may lead the clinical development team (CDT) through meeting management support and communication.
8 Manage the contractual and budget requirements for clinical strategy needs across programs including but not limited to consultants, data monitoring committees or adjudication boards.
9 Interact 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.
10 Contribute to multidisciplinary work teams evaluating and implementing continuous improvement (i.e. quality circles, SOP harmonization).
Position Qualifications and Experience Requirements
Advanced degree (MD, PhD or PharmD) in life science/healthcare required with minimum of
3 years experience in clinical research.
Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with > 5 years experience in clinical research.
Early Clinical Development experience is necessary for this role.
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
Experience working in a cross-functional, matrix environment. Exposure to global multi-
cultural teams desirable.
Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH are necessary.
Strong research skills, knowledge of scientific analysis, data mining, and basic statistical analysis principles required.
Excellent communication and presentation skills required. Experience in scientific/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. Fluent in English, oral and written.