Seaport Therapeutics is seeking someone to join their clinical operations team.  Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.   This position is based in Boston, and requires in-office presence on a flexible schedule

The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com

Responsibilities:

• Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Cross-functional partnership across R&D team to ensure scientific and medical priorities are well integrated.
• Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
• Provide clinical leadership to CROs and other vendors.
• Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
• Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
• Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
• Interact with clinical research investigators and sites.
• Oversight of study team and site training
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
• Management of study drug distribution and accountability processes and documentation
• Oversight of study start-up, study management, data cleaning, and study closeout activities
• Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.
• Provides leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.

Requirements:

• BA/BS degree in Health or Life Sciences required
• Minimum of 6 years of clinical operations experience in a pharmaceutical or biotech or CRO setting Exceptional communication and interpersonal skills
• Positive team orientated attitude
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities
• Creative problem solver
• Ability to travel is required
• CNS therapeutic experience strongly preferred