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Seaport Therapeutics · 20 hours ago

Senior Director, Clinical Development

Boston, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$280K/yr - $310K/yr

5+ years exp

Seaport Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel neuropsychiatric medicines. They are seeking a hands-on clinical development leader to oversee global clinical programs, manage clinical trial design and execution, and collaborate with various stakeholders in the field of neuropsychiatry.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Establish the clinical development strategy and hands-on tactical execution plans on programs against the current and future development portfolio

Manage effective internal and external relationships, such internally with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators

Medical oversight of ongoing clinical trials in the neuropsychiatric therapeutic area

Lead clinical sections of regulatory documents (IND, BLA/NDA)

Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities

Work with Scientific Communications/ Medical Affairs team members to organize and prepare for advisory board meetings

Work with other members of the Program team through all phases of development through commercialization

Prioritize and develop the company’s current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions

Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process

Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards

Actively participate in strategic planning for the clinical development organization and provide support to business development / licensing activities

Maintain an understanding of competitors and clinical developments in relevant therapeutic areas

Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators

Qualification

Clinical development experienceNeuroscience expertiseIND/NDA submissionsClinical trial designGCP/ICH/FDA requirementsInterpersonal skillsPresentation skillsWritten communicationVerbal communicationCollaborative work

Required

MD training in psychiatry and/or neuroscience required

5+ years of clinical development experience within a biotech/pharmaceutical setting with a strong track record of successful clinical program execution in the field of neuropsychiatric drug development

Prior clinical/academic experience required as well

Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents

Demonstrated track record and experience working cross-functionally in a collaborative and productive manner across R&D functions and beyond

Exceptional interpersonal, influencing, presentation, and written and verbal communication skills

Understanding of the general healthcare environment in the US and elsewhere-including laws, regulations, and evolving market access trends and issues

Knowledge and experience of building clinical development infrastructure aligned with the needs of a growing organization