Clinical Scientist (Late Stage)

MBX Biosciences•Burlington, MA

2d•Hybrid

About The Position

The Clinical Scientist provides clinical and scientific expertise to deliver clinical studies in early- and/or late-stage development. Under the supervision of a Director or Senior Director in Clinical Development, this role is responsible for hands-on implementation and execution of assigned studies in collaboration with cross-functional study teams. Clinical pharmacology studies may be included based on company needs. The role provides clinical and scientific oversight from study start-up through close-out and results reporting; leads development of study protocols, amendments, and related documents; contributes to regulatory submissions and responses; and develops study execution plans with cross-functional leads. The Clinical Scientist also supports vendor selection and management, trains study team members, reviews emerging safety and efficacy data, identifies and resolves study issues, and contributes to analysis, interpretation, presentation, and reporting of study results. The position requires periodic business travel and a hybrid work schedule consistent with local office practices and the company's in-office policy.

Requirements

Degree in Life Sciences (PhD, PharmD, RN, or NP).
At least 3 years of hands-on early- and/or late-stage clinical development experience in a pharmaceutical or biotechnology organization.
Understanding of the drug development process from pre-IND through registration.
Understanding of drug development functional areas, including preclinical, clinical pharmacology, regulatory, pharmacovigilance, drug supply, biometrics, and clinical operations.
Ability to understand, interpret, and communicate clinical information, including clinical study data, literature reviews, and current treatment practices, to inform decision-making and clinical strategy.
Effective communication and influencing skills across functions.
Strategic and proactive thinking, strong scientific and analytical skills, decisiveness, and ability to contribute as a respected team member.
Ability to work effectively in a collaborative, highly matrixed team environment, achieving results through influence, cooperation, and incorporation of multiple points of view.
Self-motivation, attention to detail, and problem-solving ability.
Excellent organizational skills and ability to embrace change and multitask in a fast-paced environment.
Proficient knowledge of GCP/ICH.
Proficiency in Microsoft Word, Excel, PowerPoint, and Electronic Data Capture.
Ability to travel periodically based on business needs.

Nice To Haves

Late-stage clinical development experience.
Clinical research background in metabolic diseases.

Responsibilities

Provide clinical and scientific oversight of clinical study execution from start-up to close-out and results reporting.
Lead authoring of clinical study protocols, amendments, and related study documents, including drug-specific risk language, informed consent forms, study training materials, pharmacy manuals, and laboratory manuals.
Contribute to regulatory study documents, including clinical sections of IND, NDA, and CTA submissions, investigator brochures, annual reports and updates, and clinical sections of health authority responses.
Develop clinical study execution plans in collaboration with cross-functional study leads.
Share responsibility with the study Clinical Operations Lead for establishing and maintaining regular cross-functional study team meetings.
Contribute to the selection and management of study vendors, including CROs, central laboratories and imaging providers, clinical sites, EDC, IRT, and TMF vendors.
Train internal and external study team members on medical and scientific aspects of the study at SIVs and other applicable forums.
Review and monitor emerging clinical study safety and efficacy data, including establishing the medical monitoring plan, conducting medical review, and documenting its outcomes.
Work with the Study Medical Lead and Director or Senior Director of Clinical Development to report study progress and communicate identified medical or operational issues in a timely manner.
Proactively identify and review emerging study issues by engaging with the CRO, vendors, and cross-functional study leads.
Develop strategic solutions to study issues and collaborate with relevant study team members to resolve them.
Support the review, analysis, and interpretation of clinical study results.
Contribute to clinical study report development and ensure timely finalization.
Present clinical study data to internal or external stakeholders as needed.
Maintain current knowledge of pertinent therapeutic areas.
Perform other responsibilities as assigned.