AddressPosition Summary
The Senior Clinical Research Scientist (CRS) will provide scientific expertise necessary to design and deliver clinical studies and programs. Incumbent will be responsible for planning, implementation, and execution of assigned clinical trials with minimal to moderate level of supervision. This individual will support clinical development planning in collaboration with other members of the clinical development team.
Key Responsibilities
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- In collaboration with biostatistics, clinical pharmacology, translational research, clinical operations and data management, contributes to the development of the plan to execute on trial design.
- Collaborate with clinical development on the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring emerging clinical data related to safety and efficacy. Develops sound, strategic solutions to issues and collaborates with the clinical team to ensure issue resolution.
- Works closely with the medical monitor to assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
- Provide scientific input to the efficacy and safety endpoint objectives of a trial and assure efficient and innovative clinical study designs.
- Provide clinical oversight of the study execution in collaboration with all members of the clinical program/study team.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
- Develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Work as part of a highly matrixed organization to support the operational effectiveness of study execution.
- Travel as necessary to national and international conferences and study sites.
- Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses), as appropriate.
- Collaborate and liaise between external partners for scientific advice.
- Author/review abstracts, presentations, and manuscripts for external publications
- Independently manage the scope of work, objectives, quality of deliverables, and other activities of assigned projects.
Education & Experience
- Degree in Life Sciences (PhD, PharmD, RN, NP) with 6+ or more years drug development & clinical research experience in a pharmaceutical or biotechnology organization.
- At least 5+ years of clinical, technical/operational experience in planning, executing, reporting and publishing clinical studies.
- Strong analytical scientific background with industry clinical development experience in hematology or rare genetic diseases
- Candidates must possess effective communication and influencing skills.
- Thorough understanding of the drug development process from pre-IND through registration and post-registration required.
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Ability to interpret, analyze, and present clinical data in order to inform decision-making and set clinical strategy.
- Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader.
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
- Excellent communications skills and ability to influence across multiple functions.
Additional Skills and Qualifications
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Proficient knowledge and skills to support program specific data review, trend identification, and data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture
- Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industry experience.
- Strong medical knowledge and experience in clinical development in all phases.
- Previous experience managing clinical trials.
Domestic and international travel may be required (approximately 10-25%); this includes periodic travel to MBX headquarters.
Company Overview:
MBX Biosciences is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide (PEP) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives.
A distinguishing strength of MBX is world-class proprietary peptide drug discovery. Our team is driven to transform the current treatment landscape with highly efficacious, safe, and convenient medicines that are designed to address unmet needs in both rare and prevalent endocrine diseases. We are combining our deep expertise in peptide discovery and development with our novel, proprietary platform technology to advance our pipeline.
Our lead programs have clinically validated targets and attractive endocrine disease market opportunities. MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for the treatment of hypoparathyroidism. The company is building a pipeline of additional product candidates to treat endocrine disorders that will enter Phase 1 development in 2023.
MBX is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, OrbiMed, Wellington Management, RA Capital and Norwest Venture Partners. We are based in the Indianapolis area and growing rapidly in a hybrid workplace environment. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, passionate about their work, and able to work in a dynamic environment.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
