Medical Director

Building on our founders’ Nobel-prize winning discoveries in RNA interference, Atalanta Therapeutics is developing novel Di-siRNA therapies to treat severe neurological diseases at the root cause. With a robust internal pipeline along with key strategic partnerships in place, Atalanta is poised to make a meaningful difference in people’s lives. We are driven by a culture of integrity, respect, collaboration, and continuous learning. We are located in Boston’s vibrant Seaport district near South Station.

POSITION SUMMARY:

We are seeking an experienced Medical Director to lead and oversee clinical development activities for our neurological and CNS disease pipeline. Reporting to the Chief Medical Officer, the Medical Director will work closely with cross-functional teams, including clinical operations, regulatory affairs, and research, to design and implement clinical trials, interpret data, and support regulatory submissions. This position will involve key leadership responsibilities and serve as a medical and scientific thought leader, including interacting with external experts, regulatory agencies, and patients to ensure the success of our programs. The Medical Director will be able to take on increasing leadership responsibility over time and help shape and execute the medical strategy for Atalanta’s pipeline.

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%

Atalanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.