Description
Medical Director
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 Medical Director 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 plan, indication selection, protocol design, safety monitoring, data analysis, document authorship, stakeholder interaction, publication strategy, regulatory engagement, and literature reviews. The ideal candidate will demonstrate strong scientific expertise, leadership acumen and a proven track record in similar roles at biotech companies.
Key Responsibilities
- Protocol Development: Lead the development of study protocols for investigational products in SAD & MAD healthy volunteer studies, as well as in CNS 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 Advisor Board meetings, Data Monitoring Committees, and other data review committees. Preparing updates and synthesize data reports.
- Document Preparation: Author clinical study protocol and reports, investigator brochures, and other regulatory documents. Develop training materials for study teams.
- 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 IND submissions, investigator brochures, and communication with regulatory agencies.
- Literature Review: Conduct literature reviews to inform development strategy and scientific hypotheses. Stay updated on relevant literature for program development.
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 5+ years of clinical trial experience in CNS drug development in the biotech or pharmaceutical industry. Applicants with other relevant post graduate degree will be considered but must demonstrate significant and relevant clinical development experience.
- Expertise in developing CNS neurorestorative therapies for MS, ALS, AD, or related disease types.
- Strategic thinker with excellent communication skills and scientific judgement.
- Ability to independently manage external and internal interactions with key stakeholders to support a global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
- Desired experience in health authority interactions and regulatory submissions.
- Ability to perform and bring out the best in others on a cross-functional team.
- Strategic thinker with a results-oriented mindset, capable of driving projects forward in a fast-paced, dynamic environment.
- Experience managing clinical CROs and overseeing clinical operation is preferred.
The Perks
Myrobalan team members have access to competitive compensation, health coverage (including medical, dental and vision), as well as life insurance and short term and long-term disability insurance. We value work life balance, so we do offer flexibility for hybrid work depending on role and business conditions. We offer an excellent 401(k) package and generous time off benefits including parental leave and winter holiday shutdowns. Employees routinely participate in training and development opportunities to enhance their career growth.
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