Medical Director

RESPONSIBILITIES:

• Provide strategic medical leadership for clinical development programs focused on neurological diseases, including early-phase trials (Phase I/II) and pivotal trials (Phase III).
• Collaborate with clinical operations, biostatistics, translational medicine, and regulatory teams to design robust, scientifically sound clinical trials that address unmet needs in neurological disease.
• Develop and oversee clinical trial protocols, ensuring they are aligned with company strategy, regulatory requirements, and the latest scientific advancements in neurology.
• Develop and implement high quality clinical studies to support the clinical development plans including biomarker and translational studies, natural history studies, and clinical trials.
• Provide medical monitoring, safety assessments and oversight for all clinical trials while ensuring that safety and efficacy data are collected and analyzed in a timely and scientifically rigorous manner
• Provide expert medical input into the development of overall clinical and medical strategies for neurological disease programs.
• Engage with key opinion leaders (KOLs), academic institutions, and clinical investigators to gather insights and refine clinical program strategies.
• Develop and implement medical education programs and publications that share clinical trial findings with the broader neurological community.
• Actively contribute to the development of presentations, abstracts, manuscripts, and other scientific communications for medical conferences and peer-reviewed journals.
• Provide medical expertise for regulatory submissions (e.g. INDs, CTAs, NDAs) and participate in interactions with regulatory agencies (e.g. FDA, EMA) during clinical trial design and approval processes.
• Ensure clinical trials comply with Good Clinical Practice (GCP), ICH guidelines, and other regulatory requirements specific to neurological disease trials.
• Review and approve clinical study reports, regulatory documents, and clinical sections of marketing applications.
• Work closely with internal teams, including clinical operations, regulatory affairs, and research & development, to ensure the alignment of clinical strategies with overall company objectives.
• Provide medical insights into clinical data analysis, helping to shape trial design adjustments, endpoint selections, and post-hoc analyses as needed.
• Contribute to the preparation of regulatory submissions, including clinical summaries and scientific rationales.
• Represent Atalanta at scientific and medical conferences, presenting clinical data and engaging with the scientific community to advance Atalanta’s position in the field of neurological diseases.
• Cultivate relationships with KOLs, healthcare providers, and other external stakeholders to stay abreast of emerging trends and advancements in neurology.
• Shape and execute the medical strategy for Atalanta’s portfolio, ensuring alignment with therapeutics area trends, scientific developments, and patient needs.

QUALIFICATIONS:

• Doctoral degree (e.g. MD, PhD or equivalent) with board certification in neurology, neuroscience or related field preferred
• A minimum of 3 years of experience in clinical development within the biotechnology or pharmaceutical industry, preferably with experience in CNS, rare disease, or related therapeutic area
• Experience in clinical practice treating patients or subspecialty training in behavioral neurology, movement disorders, epilepsy, pediatric neurology, or neuromuscular disorders is preferred
• Extensive 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 is preferred
• Proven ability to lead cross-functional teams and manage complex clinical programs
• Experience with regulatory submissions and interactions with regulatory authorities (FDA, EMA)
• Strong leadership and mentoring capabilities, with experience managing and developing teams in a fast-paced and ever-evolving environment
• Excellent communication skills, both oral and written, with the ability to present complex data in an accessible manner to diverse audiences
• Experience with medical writing, scientific publications, and presentations at major medical conferences
• Strong problem-solving, decision-making skills, with a focus on patient-centered outcomes
• Willing and able to travel domestically and internationally 15-20%