Director, Clinical Operations
MBX Biosciences, Inc. is a preclinical-stage biotech company committed to creating therapies to treat rare endocrine diseases where there is inadequate treatment available. MBX’s leadership team has collaborated successfully over several decades to discover, develop and commercialize first-in-class endocrine therapeutics. A distinguishing strength of MBX is world-class proprietary peptide drug discovery.
MBX’s clinical program for its lead clinical candidate will commence in mid-2021. The company is building a pipeline of additional product candidates targeting rare endocrine disorders that are targeted to enter Phase 1 development by the end of 2021.
The Director of Clinical Operations will be responsible to manage overall clinical study operations as well as ensure compliance with GCP and regulatory guidelines. This individual will report to the Chief Medical Officer and will lead the development of study operational plans including management of the CRO, vendors and sites, development of project plans, budget and resource management.
Duties and Responsibilities Include (but not limited to)
- Responsible for the strategic and operational oversight, management, execution and delivery of the clinical program objectives
- Accountable for managing and driving study level timelines, budgets and quality targets to meeting corporate goals, working closely with internal leadership and CROs
- Manage resources to ensure cost, time and quality goals are met
- Establish key deliverables and key performance indicators in management of CRO and vendors to ensure the successful execution of clinical trials to agreed timelines
- Ensure effective communication and team alignment with cross-functional leadership goals and company objectives
- Manage the study level budget and tracking against budget with all parties
- Actively contribute to technical and study design discussions, providing input to study concepts, protocols, informed consent forms, clinical study reports
- Manage study activities including investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks/study closeout.
- Author and/or provide input and implement program level and study level documents to support operational plans including study-specific training, system builds, CRF designs, UATs
- Ensure consistency between clinical studies for a clinical program
- Ensure risk planning is ongoing throughout the study. Identify issues and risks, develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach with team and service providers
- Participate and present at investigator meetings and ability to lead site qualification, initiation, oversight/co-monitoring, and closeout visits
- Manage regulatory documentation from clinical sites and investigators required for the initiation and continuation of clinical studies
- Lead and/or contribute to process improvements/initiatives and SOPs
- Implement and oversee inspection readiness activities
- Collaborate with internal stakeholders to generate high quality clinical study reports, investigator brochures, clinical protocols, publications and presentations of clinical study results
- Prepare, coordinate and maintain clinical sections for regulatory submissions
- Bachelor’s degree required; an advanced degree (i.e., PhD, PharmD, or other) is preferred
- Minimum of 10 years pharmaceutical/biotech industry experience in clinical operations with demonstrated project management skills and cross-functional leadership is required
- Experience in rare diseases and/or endocrinology is a plus
- Experience in working in a start-up environment is strongly desired
- Extensive clinical trial conduct (Phase 1 through Phase 3) and global clinical operations experience, along with a deep understanding of the processes associated with project and study management yielding study completion on time, to budget, and at the required quality
- In depth knowledge of ICH/GCP, clinical, monitoring, and regulatory operations and guidelines
- Prior experience in managing a CRO
- Experience in understanding key drivers impacting budgets, forecasting skills and building a clinical trial budget and managing it to budget
- Inspection readiness and inspection experience is a plus
- Excellent verbal and written communication, analytical and project management skills
- Ability to develop and maintain strong, collaborative relationships with internal and external stakeholders
- Exceptional attention to detail and organizational skills
- Ability to think strategically, multi-task well, proactively problem-solve and manage challenges in a fast-paced environment
Location: Carmel, Indiana
We would consider telecommuting but prefer local candidates.
Interested applicants should submit a cover letter and resume to BioSpace.
MBX Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. MBX is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. We encourage applicants of all ages.