Sr. Clinical Scientist

Primary Duties

As a key member of the Development Sub-Team, the Senior Clinical Scientist will contribute to the successful execution of the clinical programme of one or more assigned gene therapy projects within the Liver/Systemic therapy area. Key job responsibilities include, but are not limited to, study design/planning, protocol development and execution, medical monitoring, data interpretation and documentation. The Senior Clinical Scientist will also support regulatory interactions and submissions including scientific advice meetings, IND/CTA filings, regulatory document updates (e.g. DSUR, Investigator Brochure) and information requests from health authorities.

Responsibilities

Job Function and Description

Support creation and progression of the Clinical Development Plan and its periodic reviews. Play an active role in planning, conducting and evaluating ongoing clinical trials to ensure successful execution. Support medical monitoring activities for ongoing clinical trials. Support/manage preparation of materials for trial-related clinical committees such as Steering Committees, Data Monitoring Committees, Adjucation Committees, etc. Support Medical Lead/Study Physicians on all trial related education for sites, staff, vendors and other Spark functions. Liaise and communicate with other functions including Clinical Operations, Biometrics, Safety, Research and Translational Sciences, Regulatory Affairs, Patient Advocacy and Medical Affairs to coordinate the clinical efforts on project related issues. Contribute to the preparation of all clinical trial related documents submitted to health authorities and ethics committees/IRBs including the clinical trial protocol, Investigator Brochure and Informed Consent Form. Review and interpret clinical data for inclusion in Clinical Study Reports and assist with authoring. Support/manage preparation of materials for presentations to internal governance bodies. Support/lead in the preparation of abstracts, publications, posters and oral communications for scientific meetings. In all activities, ensure compliance with GCP, Clinical Operating Guidelines and Standard Operating Procedures.

Education and Experience Requirements

PhD, PharmD or other qualification with strong professional experience (e.g., RN, NP, PA). At least 4 years of experience in clinical drug development within the biopharmaceutical industry. Experience of working directly on projects in early clinical development would be an advantage Knowledge of the regulatory path across the various health authorities (FDA, EMA, PMDA, etc). Knowledge and experience in rare diseases, particularly in the area of neuromuscular diseases or lysosomal storage disorders is preferred.

Key Skills, Abilities, and Competencies

Ablility to quickly understand and apply scientific concepts in a clinical setting, and to critically evaluate, interpret and synthesize scientific data. Ability to manage multiple tasks/programs with competing deadlines/priorities. Ability to establish strong scientific partnerships with internal and external key stakeholders. Excellent verbal and written communication skills in English.

Complexity and Problem Solving

Must be able to evaluate, interpret and integrate scientific data from multiple sources, presenting and critically discussing clinical trial data in internal and external meetings. Must be able to apply the relevant principles, concepts, practices and standards to conduct GCP compliant clinical trials.

Internal and External Contacts

Works within assigned project teams and role is accountable to the Development Sub-Team leader(s). The Senior Clinical Scientist may also interact with senior internal management, external therapy area experts and 3rd party vendors (CRO’s) often requiring coordination between organizations/departments/teams.

Other Job Requirements

Travel up to 10%

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

Nearest Major Market: Philadelphia

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Learn more about Spark Therapeutics and view other openings.