Why MBX Biosciences?

MBX is a dynamic biopharmaceutical company led by an experienced team of company builders and drug developers, backed by some of the industry’s most respected investors.

Our team is driven to transform the current treatment landscape with breakthrough medicines, simplify management of endocrine diseases, and enable greater access for patients. We are combining our deep expertise in peptide discovery and development with our novel, proprietary platform technology to build a pipeline of the most high-impact medicines.

Our core values are transparency, integrity, teamwork and innovation. It is a testament to our culture that many of our team members have collaborated successfully over multiple decades. We emphasize development of skills through a supportive, cross-functional and entrepreneurial organization.  

Headquartered in the Indianapolis metropolitan area, MBX offers competitive compensation and a comprehensive benefits package.  We offer flexible work arrangements and want our team members to have work-life balance.  We recognize the hard work and contributions of our team members both individually and collectively. 

Please note we do not accept unsolicited resumes from recruiters and will not pay a fee for any unsolicited resume.

Current opportunities:

Chief Financial Officer

Slone Partners seeks a Chief Financial Officer for a highly innovative and rapidly growing pre-IPO biopharmaceutical company pioneering first-in-class therapies to treat both rare & prevalent endocrine diseases.  Through passion and teamwork, our client will discover, develop, and commercialize therapies where there is inadequate treatment available. The company has assembled a distinguished Board, Executive Leadership Team, and Investors group and is looking to build out finance operations in preparation for growth and to access the public markets. Reporting to the Chief Executive Officer, the CFO will play an integral role in IPO-preparedness, subsequent capital raises, finance operations and infrastructure (people, processes, and systems), and operate as a strategic partner to Executive Leadership Team and Board. 

Required skillsets: 15+ years of progressive operational, financial leadership (preferably in life sciences/biotech environment); IPO/S-1, investor-facing/capital raise; prior/current sitting CFO or equivalent 

Special features of this position: This is an opportunity to join a well-funded and well-positioned company on the path to commercial and therapeutic success with a transformative impact to patients.   

Interested and qualified candidates should reach out directly to Alicia Montgomery, Vice President Executive Search at Slone Partners.  Aliciam@slonepartners.com

Director, Toxicology

Position Summary:

The Director of Toxicology works in a Team environment (toxicology, pharmacology, medical, regulatory, CMC) to design, interpret and report nonclinical in-vitro and in-vivo toxicology and pharmacology studies for MBX Biosciences discovery and development programs. This will include exploratory studies, and GLP studies to support regulatory filings. In addition, the Director will liaise with discovery and development colleagues to develop overall toxicology and safety pharmacology strategies.  She/He will regularly interface with internal and external colleagues to provide timely and accurate dissemination of relevant safety data. The Director will also work collaboratively with executive management to develop key program strategies which will strengthen the MBX capabilities focused on early and late clinical drug development activities for small and large molecules.  The Director will work with external partners such as CROs to conduct the necessary studies to support drug development, and to monitor study progress.

The Director, Toxicology will report to the Vice President, Pharmacology and Toxicology.

Key Responsibilities:

·        Lead preclinical toxicology programs for small and large molecules in discovery and development stages

·        Formulate preclinical toxicology strategies to then allow seamless integration into workflow to advance programs

·        Interface with internal stakeholders in discovery and development

·        Interface with regulatory agencies

·        Lead the optimization of toxicology programs by identifying, developing, and implementing screening strategies for target validation

·        Guide investigative efforts to define mechanism of toxicity

·        Work with Medical to develop nonclinical strategies, and risk-benefit approaches for molecules selected to move forward to FIH trials

·        Establish collaborations with CROs and/or academic institutions supporting MBX drug development programs

·        Provide input on strategic and tactical direction for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development. Prepare or review study reports for regulatory submission on development candidates. Write toxicology and pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA

·        Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new peptide projects

Qualifications/Requirements/Personal Competencies:

·        PhD in Toxicology, Pharmacology, or related sciences, with minimum six (6) years of professional experience in drug discovery and development 

·        Diplomate American Board of Toxicology (DABT)

·        Excellent communication and interpersonal skills, with the ability to effectively:

influence opinion and actions

communicate strategies, plans, results, and analysis

·        A mix of experience across pharmaceutical companies and toxicology CROs would be desirable

·        Demonstrated scientific excellence in the application of toxicology and pharmacology principles across pharmaceutical research and development

·        Knowledge of U.S. and International safety guidelines and requirements for pharmaceutical development

·        Experience in preparation of INDs, BLAs, NDAs

·        Record of publications and presentations at National Meetings

·        Direct leadership experience

·        Experience and success in designing non-GLP and GLP safety studies

·        Strong interpersonal skills and ability to represent Nonclinical Development in cross functional teams

·        Ability to think strategically and to provide clear direction and expectations to other team members in a highly dynamic environment

·        Strong ability to prioritize daily work based on changing business requirements

·        Self-motivated, independent, and results oriented 

·        Ability to work productively in a matrix environment, as both a team contributor and team leader, taking ownership of multiple projects 

To Apply

Interested applicants should submit a cover letter and resume to MBX’s Human Resource Department at HR@mbxbio.com.

Vice President, CMC

Position Summary:

Reporting to the Chief Scientific Officer, the Vice President of CMC works in a team environment (toxicology, pharmacology, medical, regulatory, quality) and is a critical member of the leadership team of MBX Biosciences. The Vice President of CMC is responsible for selection and oversight of CROs/CMOs/CDMOs and consultants conducting API manufacturing, formulation development, analytical method development, API/product characterization studies, stability studies, reference material management, fill/finish of clinical trial supplies, and clinical trial supply management. In addition, the Vice President will help support & define product development timelines and work in collaboration with all staff members to successfully achieve regulatory milestones.

The Vice President of CMC will manage projects from pre-clinical to scale up for product launch. The VP will utilize internal and external resources to meet the objectives of the company. Managing external consultants and the ability to develop an external network of third-party suppliers is critical to success. Given the virtual nature of the company, the ability to perform multiple tasks across several areas in a hands-on manner will be expected. The Vice President will also work collaboratively with executive management to develop key program strategies which will strengthen the MBX capabilities focused on early and late clinical drug development activities for small and large molecules.

Role and Responsibilities

· Lead all CMC activities for small and large molecules from pre-clinical through development stages.

· Contribute to the overall strategic plan of the company.

· In collaboration with internal & external resources, support the advancement of early-stage pipeline into preclinical, clinical, and commercial stages.

· Manage the CMC operating budget and meet financial objectives.

· Lead the evaluation and selection of external CROs/CMOs/CDMOs and serve as the primary contact for these strategic partners.

· Identify external consultants that can bring the necessary technical knowledge to meet goals and solve CMC issues.

· Provide guidance on what is needed to all external partners and ensure that each partner has a strong track record, the right technical capabilities, and is a cultural match for the needs of the MBX team.

· Liaise between R&D, quality, and regulatory functions bridging these functional areas to ensure successful development of processes for the ultimate manufacture of clinical candidates through external partnerships.

· Meet all deliverables to ensure projects remain on timelines (data, clinical supplies, reference materials, etc.)

· Champion and maintain a culture of scientific innovation and technology development.

· Review and/or author study reports, batch records, IND sections, and other necessary documents.

· Solve complex issues where analysis of data or situations requires in-depth technical knowledge, and serve as the internal expert in sharing important data points with MBX functional team leaders.

· Work collaboratively across all disciplines in the company.

Qualifications & Requirements

· 10+ years of pharmaceutical drug development experience at a pharmaceutical or biotech company.

· PhD strongly preferred in chemistry, biochemistry, or bioanalytical chemistry.

· Excellent communication and interpersonal skills, with the ability to effectively communicate strategies, plans, results, and analysis of data.

· Experience in preparation of INDs, BLAs, NDAs.

· Previous experience in a GMP environment and a demonstrated competency in the principles and practices of GMPs.

· Understanding of process development, process transfer, and manufacturing of drug candidates.

· Knowledgeable in relevant CMC regulatory regulations and guidances (e.g., FDA, EU, ICH).

· Strong experience in strategic management, planning, and execution.

· Proven ability to manage resources and workloads.

· Strong interpersonal skills and ability to represent CMC in cross functional teams.

· Proven ability to think strategically and to provide clear direction and expectations to other team members in a highly dynamic environment.

· Strong ability to prioritize daily work based on changing business requirements.

· Experience reviewing, authoring, and editing CMC submissions; direct interface with regulatory bodies preferred.

Interested and qualified candidates should reach out directly to Alicia Montgomery, Vice President Executive Search at Slone Partners.  Aliciam@slonepartners.com

Manager/Senior Manager, Regulatory Affairs

Position Summary:

The Manager/Senior Manager, Regulatory Affairs will prepare, review, and liaise with an external submission vendor to submit pre-marketing amendments to the IND for the lead clinical asset MBX 2109. The individual will be accountable for providing strategic regulatory guidance in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines. This individual will work cross-functionally to facilitate the prompt review and approval of submissions and manage the preparation of correspondence to FDA. This role is both strategic and hands-on, requiring the ability to understand the regulatory environment, communicate priorities to stakeholders, and build relationships with external vendors. This individual will report to the Vice President, Global Regulatory Affairs. 

Key Roles & Responsibilities

·        Compile, write and review sections for IND submissions (amendments, Annual Reports, safety, etc.) ensuring that they are in conformance with applicable FDA guidance and that the highest regulatory standards are met

·        Critically review documentation intended for submission to the FDA for internal consistency

·        Plan and implement regulatory activities in support of lifecycle management.

·        Provide support in compiling/writing Regulatory Agency meeting requests and briefing documents

·        Provide regulatory input for development projects and as required function as the regulatory expert on project teams

·        Interpret regulatory policies and guidance, monitor changes in the regulatory landscape and provide advice accordingly to ensure that the business needs are in compliance

·        Coordinate with functional team members to establish timelines to ensure that complete and accurate submissions are prepared according to plan

·        Build and maintain effective relationships with external stakeholders

Job Requirements

·        Previous IND/NDA submission experience is a must.

·        Experience managing multiple products simultaneously and different stages of the product lifecycle is desirable.

·        Demonstrates in-depth and relevant knowledge and understanding of FDA guidelines and federal regulations with demonstrated ability to successfully apply these to a compliant work output

·        Experience in FDA regulations on device products is highly desired

·        Minimum of a BS degree in Pharmacy, Chemistry, Biology or Microbiology

·        Minimum of 5 years experience in FDA regulatory submissions and maintenance activities including INDs, NDAs, DSURs, briefing packages, response to FDA questions

·        Ability to work well autonomously owning decisions and within a multi-disciplinary virtual team environment

·        Ability to think strategically, multi-task well, proactively problem-solve and manage challenges in a fast-paced environment

Qualified applicants only please send resume to HR@mbxbio.com.

AAP/EEO Statement
MBX Biosciences, Inc. 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.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.