- Provide psychiatric expertise to HMNC’s clinical-stage studies in depression and treatment-resistant depression, applying specialist clinical judgment to trial conduct and data review.
- Contribute practical medical input to protocols and study documents, including study objectives, patient population, eligibility criteria, endpoints, assessment schedules and clinical relevance.
- Bring the perspective of clinical practice to trial feasibility, patient burden, recruitment, site engagement and the practical implementation of study procedures.
- Review emerging clinical safety and tolerability data, and support ongoing benefit-risk assessment with the CMO and relevant functions.
- Provide oversight of CRO medical-monitoring, including review of eligibility questions, concomitant medicines, adverse events and other protocol or safety queries, following study procedures and escalation pathways.
- Provide Sponsor oversight and approval, as needed, of any Pharmacovigilance reportable events.
- Review protocols, amendments, medical monitoring plans, investigator brochures, informed consent materials, safety narratives, clinical study reports and briefing documents.
- Work with investigators, site staff, CRO medical monitors and external experts to resolve medical questions and support consistent application of study protocols.
- Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management and Pharmacovigilance on study conduct, safety review and interpretation of clinical data.
Medical Expert Psychiatry (m/f/d)
München, Remote
Full-time
Permanent employee
Job Summary and Responsibilities:
We are looking for a board-certified psychiatrist with strong clinical experience in mood disorders and a few years of exposure to clinical development or clinical studies. You will provide hands-on medical input to HMNC’s programs in depression and treatment-resistant depression, including protocol development, medical monitoring, safety review and interpretation of emerging clinical data. Working closely with the Chief Medical Officer, VP Clinical Development and Clinical Development team, you will support protocol development, Sponsor oversight of medical monitoring/safety and the resolution of medical questions during clinical studies. The position combines specialist psychiatric judgment with practical study experience and complements HMNC’s existing clinical development leadership.
Your profile
- Medical degree and board certification or a recognised specialist qualification in psychiatry, such as Facharzt/Fachärztin für Psychiatrie und Psychotherapie or the equivalent qualification in the relevant country.
- Several years of clinical experience in psychiatry, including direct assessment and treatment of patients with major depressive disorder; experience with treatment-resistant depression is preferred.
- Strong understanding of depression treatment pathways, unmet medical needs, clinical outcome measures and the practical realities of psychiatric care.
- A few years of exposure to clinical research or clinical development, for example as a CRO medical monitor, in a sponsor-side medical role, as an investigator or through work at a clinical study site. Practical medical-monitoring experience is a strong advantage.
- Working knowledge of GCP and hands-on familiarity with clinical trial conduct, including eligibility assessment, safety reporting, adverse-event review, protocol adherence, safety escalation and benefit-risk assessment.
- Ability to assess clinical data and literature critically and communicate conclusions clearly to specialist and cross-functional audiences.
- Collaborative and pragmatic working style, sound medical judgment and clear communication skills. Fluent English is required; experience with international studies is of advantage.
Why HMNC?
- An inspiring work environment in a motivated and international team with flat hierarchies.
- A permanent position with a competitive salary in an early stage, growing and dynamic company based in Munich.
- Multiple learning and development opportunities.
- A growing benefit portfolio including a yearly career development budget.
- Flexible and family-friendly working hours with the possibility of individual solutions including remote work.
- Good connection to public transportation as well as a parking garage in the office building.
- We value diversity – regardless of gender, nationality, ethnic and social origin, religion/belief, physical abilities, age as well as sexual orientation and identity.
About us
HMNC Brain Health (HMNC) is a clinical-stage neuroscience company developing new therapies for mental health disorders. With an initial focus on difficult-to-treat depression, including treatment-resistant depression (TRD) and adjunctive therapies for major depressive disorder (MDD), HMNC’s pipeline includes two late-stage programs. Lead asset Ketabon (KET01), partnered with MEDICE for European commercialization, is an oral prolonged-release ketamine formulation for TRD, designed for at-home use. Nelivabon (BH-200) is a first-in-class oral vasopressin receptor antagonist targeting the stress axis, with potential in adjunctive MDD/ TRD. By advancing targeted and accessible treatment options, HMNC aims to address significant unmet needs of millions of patients who are not helped sufficiently by existing mental health therapies. The Company is headquartered in Munich, Germany. Find out more at www.hmnc-brainhealth.com and connect with us on LinkedIn.