Job Detail

Description

Position Summary:

The Clinical Scientist, Early Stage Clinical Development, works in cross-functional Clinical Team(s) to move new potential therapies from preclinical to early clinical development and is responsible for developing study protocols, study conduct and maintenance, and study read out. This involves collaboration with a multitude of other functions. The successful candidate has demonstrated proficiency in conducting Phase I – II clinical studies, ideally in oncology/ hematology Therapeutic Area, and is adept at managing relationships across collaborations and with the external medical community. 

Functionally the position reports to the Senior Medical Director who represents the Early Stage Clinical Development Team at the Project Team Level.

Principal Responsibilities:

• Develops medical and scientific aspects of study protocols, informed consent forms and other relevant clinical documents (e.g. SAPs, IDMC and SMC Charters) including study reports


• Key contact for Study Management Team


• Contributes to regulatory documents such as investigator’s brochure, briefing packages


• Communicates scientific data to internal/external peers, including abstracts, publications, and presentations for scientific meetings


• Leads (or supports as required) monitoring, review, analyzing and interpreting safety, efficacy, pharmacology, and translational science data from clinical trials with input from the study or program Physician/Medical Monitor


• Attends (in person or by TC) the Site Initiation Visits, to present study design and protocol


• Leads the compilation & interpretation of data for and from the dose escalation committee/ safety monitoring committee, in collaboration with the program physician/Medical Monitor


• Develops and builds investigator and site relationships to support site selection and study start up activities


• Represents Seattle Genetics as a support for external meetings such as advisory boards and Investigator meetings


• Contributes to regulatory submissions (e.g. INDs, CTAs) to European, US and other regulatory agencies


• Conducts literature reviews and prepare summaries to support clinical development programs


• Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates

Qualifications:

• Advanced clinical/science degree (e.g. MD, PharmD, PhD) or a comparable qualification


• Demonstrates a passion for helping patients with cancer and for the science of oncology


• Experience in pharma/biotech industry, or relevant equivalent clinical, or laboratory research field


• In-depth understanding of Phase I-II drug development, at least 5 years’ experience with clinical trials


• Advanced understanding of clinical practice across tumor types and how clinical practice is evolving with the introduction of new therapies


• Well-versed in data cleaning, data capture, monitoring and reporting tools and familiar with ICH-GCP regulation and regulatory guidance documents (especially in European Union and Switzerland) about clinical trials


• Experience authoring clinical trial protocols and/or study results and applying organizational SoPs


• Experience working in a matrix environment and interacting with a variety of experts outside (investigators, partners) and inside the company (e.g. clinical operations, regulatory affairs, biostatistics, clinical pharmacology, CMC, project management)


• Strong presentation skills, effective at summarizing and presenting the key considerations and decision-points


• Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and manage through conflict


• Proven ability in problem solving and issue management that is solution focused


• Experience in collaborating externally in terms of clear requirements for influencing delivery and scientific engagement


• Collaborative style with internal company leadership, external development partners and investigators/medical professionals 


• Is a team player, works well in a team environment both as leader and key contributor


• Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds, and geographies


• Fluent in English (speaking/writing), additional European language a plus