Seaport Therapeutics

Executive Director/Vice President, Clinical Development

Boston, MA · Exec

Sponsorship not specified$297k-$340kDetected 21 days ago

GCPBusiness DevelopmentRecruitingClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationPublic SpeakingBiostatisticsRegulatory Affairs

About the role

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.
Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders.
For more information, please visit www.seaporttx.com.

Responsibilities

Seaport Therapeutics is seeking a hands-on clinical development leader to drive the strategic and operational execution of our global clinical programs across current and future pipeline assets.
Establish and drive the clinical development strategy and hands-on tactical execution plans on programs against the current and future development portfolio.
Lead clinical sections of regulatory documents (IND, BLA/NDA).
Prioritize and develop the company's current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions.
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.

Requirements

MD training in psychiatry and/or neuroscience required.
8+ (ED) 10+(VP) 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.
Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
Experience with Phases I-III clinical development required.
Occasional work travel as required.

Nice to have

Experience with mood/anxiety disorders preferred.

Compensation

The expected salary range for this role at the Executive Director Level is $297,000-$340,000 $the expected salary range for the role at the Vice President Level is $324,000-370,000 with the final title and offer based on experience, market

Benefits

Medical oversight of ongoing clinical trials in the neuropsychiatric therapeutic area.
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.
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.
Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators.

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