Interim / Part-time CMO
Job Type
Part-time
Description

About Us


Myrobalan Therapeutics is a biotechnology company headquartered in Medford, Massachusetts, with a focus on developing oral neurorestorative therapies aimed at reversing key pathologies underlying brain dysfunctions and CNS conditions. We apply our deep knowledge of neurological processes such as demyelination and neuroinflammation, and innovative drug discovery tools, to create highly selective and brain-penetrant therapeutic candidates that are uniquely positioned for treating CNS conditions with significant unmet medical need. Our rich pipeline of novel remyelination and anti-neuroinflammation programs are being advanced with the strategic support of renowned institutional co-founders and a leading chemistry partner. Myrobalan is committed to a transformed future in which patients with degenerative CNS conditions can access safe and effective medicines offering restorative potential.


We are a highly experienced team of exceptional members who are committed to supporting each other in the pursuit of our company’s mission. We are excited to grow and welcome colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.


The Perfect Addition to Our Team


You embody our company values of being mission-driven, operating with humility and scientific rigor and are committed to being an excellent team player. You are analytical and detail oriented. You thrive in fast-paced collaborative environments and can manage multiple projects concurrently. You are highly dependable and accountable for your work. 


The Opportunity


As the Interim CMO reporting directly to the CEO, you will be a vital contributor to the clinical development of Myrobalan’s anti-

neuroinflammation and remyelination programs. The role will build and grow the clinical function, lead clinical study related activities, collaborate with cross-functional program teams and support critical regulatory activities. Key responsibilities include developing early clinical development strategy and serve as clinical expert in internal and external interactions with investors, potential BD partners, clinical KOLs and regulatory agencies. The ideal candidate will demonstrate strong scientific expertise, leadership acumen and a proven track record in similar roles at biotech companies. This position will have the opportunity to covert to a full-time CMO position after one year of service. 


Key Responsibilities

  • Protocol Development: Lead the development of study protocols for investigational products in healthy volunteer studies and biomarker-guided signal seeking studies in neurodegenerative disease indications, while ensuring compliance with regulatory standards and operational feasibility.
  • Clinical Study Oversight: Manage the execution of clinical studies, including data management, safety monitoring, study closure, and overseeing clinical CROs.
  • Program Support: Lead Clinical sub-team and represent the clinical function at Program team meetings, facilitate Scientific Advisory Board meetings, Data Monitoring Committees, and other data review committees.
  • Stakeholder Engagement: Engage with key medical experts, scientific advisors and industry experts to synthesize their insights for the establishment and enhancement of clinical development strategies. Liaise with internal and external stakeholders to operationalize program-level clinical development strategies and achieve clinical trial objectives.
  • Clinical Expertise: Serve as an internal clinical expert to support program teams. Collaborate with clinical science consultants to establish publication strategy. Work with Regulatory Affairs on global regulatory submissions, investigator brochures, and communication with regulatory agencies.

Requirements


At Myrobalan, our passion for the science, our devotion to patients, and our commitment to each other is embodied in our company values. They are:

  • Mission: Focused passion creating breakthroughs for patients
  • Humility: Leading humbly and learning from experience
  • Rigor: Guided by scientific integrity and propelled by perseverance
  • One Team: Empowered by respect, trust and candor 


To thrive in this role, you will need to come with:

  • MD or MD/PhD with 15+ years of clinical trial experience in CNS drug development in the biotech or pharmaceutical industry. Experience in neurodegenerative disease, such as MS, ALS, AD and PD, is strongly preferred. 
  • Deep expertise in early clinical development and profound understanding of global regulatory and compliance requirements governing clinical trials. Experience with clinical trials in Australia is strongly preferred. 
  • Strong track record in building and maintaining relationship with clinical KOLs, business collaborators and key stakeholders to support a global scientific and business strategy.
  • Strategic thinker with excellent communication skills, scientific judgement and a results-oriented mindset, capable of driving projects forward in a fast-paced, dynamic environment. 
  • Experience managing clinical CROs and overseeing clinical operations is preferred.
  • Able to contribute 25% of time in-person and virtually according to business need, including occasional evening meetings.