Careers
The team at Seaside Therapeutics is dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families impacted by disorders of brain development. If you share our passion and are interested in potentially joining our team, we have the following positions open.
Qualified candidates are encouraged to submit a resume and cover letter to careers@seasidetherapeutics.com.
No phone calls please. Resumes form third party vendors will not be accepted
Benefits: Seaside Therapeutics offers a competitive benefits package including comprehensive health, 401(k), vacation and a bonus plan. Seaside Therapeutics is an equal opportunity employer.
Clinical Program Manager
Seaside Therapeutics is creating new drug treatments to correct or improve the course of Fragile X Syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families.
Position Summary
The Clinical Program Manager is responsible for input into and oversight of the operational aspects of a clinical program.
Experience and Education:
- BS degree with a minimum of 5 years of clinical research experience in the pharmaceutical/biotechnology industry or within a Clinical Research Organization
- Clinical study management experience, including CRA management
- Thorough knowledge of the clinical research process, FDA regulatory requirements as well as ICH and GCP Guidelines
- Effective oral and written communications skills
- Ability to constructively problem solve while dealing with time constraints
- Ability to manage and influence without direct authority
- Ability to work both within a team and independently
- Ability to work with minimal supervision
Responsibilities:
- Assists with the design, planning, implementation and conduct of clinical research protocols
- Provides input to timelines, milestones and operational strategy for individual studies
- Oversees clinical supply management and safety reporting processes
- Provides input into the selection and management of external vendors
- Authors and/or reviews clinical content of protocols
- Authors, reviews and approves informed consent documents per Seaside SOPs
- Presents at investigator meetings
- Tracks study progress, including regulatory document collection, IRB approval and enrollment
- Manages field-based Clinical Research Associates (CRAs)
- Reviews case report form data for safety and efficacy parameters
- Provides input into clinical study reports
Operations Manager
Seaside Therapeutics is creating new drug treatments to correct or improve the course of Fragile X Syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families.
Position Summary
Responsible for administrative support in a number of areas including facilities, human resources and information technology.
Experience and Education:
- Bachelor degree or equivalent plus a minimum of 8+ years specialized administrative support
- Excellent written and oral communication skills
- Outstanding computer skills and associated office software (Word, Excel, PowerPoint)
- Ability to handle highly confidential information
- Outstanding organizational skills and the ability to handle multiple priorities simultaneously
Responsibilities:
- Coordinates a variety of administrative tasks.
- Manages the company's office services which includes: cleaning services, office and kitchen supplies, building management, space planning, conference rooms, shredding, utility services, security systems and communication systems. (telephones, fax machines, blackberries).
- Provides Human Resources support for recruiting such as interview scheduling. Manages employee records and consulting agreements. Assist with new employee orientation, benefits processing and follow up regarding benefit questions. Coordinate employee events such as holiday and employee meetings.
- Oversees third party support for all information technology needs. This includes web site management.
Director - Product Management
Seaside Therapeutics is creating new drug treatments to correct or improve the course of Fragile X Syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families.
Position Summary
Function as key member of the Management team to develop strategic marketing and sales direction for Seaside Therapeutics. This position reports to the Chief Operating Officer.
Experience and Education:
- BS/BA degree, MBA degree preferred.
- 10+ years in marketing and reimbursement in the pharmaceutical or biotechnology industry.
- Direct experience in the launch of a novel therapeutic is desirable.
- Direct experience in the launch of an orphan drug is desirable.
- International experience is desirable.
- Ability to work with third party consultants to support marketing activities.
- Experience in neurological disorders is desirable.
- Strong project management, planning and organizing skills required.
- Excellent communication and presentation skills
Responsibilities:
- Provide leadership in the establishment of product profiles for two distinct clinical stage therapeutics, including one where Phase 2 results are expected in the first quarter of 2010.
- Represent the commercial function as part of the project team developing the registration strategy and positioning for these and future products.
- Provide leadership in establishing pricing strategies.
- Provide leadership in the development and implementation of the reimbursement activities (coding, coverage, payment).
- Develop and implement private payor outreach strategies, monitor ongoing public and private policy issues associated with target products and platforms.
- Work closely with patient advocacy groups to understand their goals and communicate the Seaside story. Develop strong relationships with these groups.
- Establish a strategy to connect with the key conferences dealing with neuroscience and brain development. Ensure that the Seaside story is well represented.
- Develop pre-launch, launch and post-launch payor strategies to develop advocacy strategies related to key policy issues.
- Develop expert knowledge of customer/market requirements, clinical trends and competitor activities through market research, attendance at selected medical society meetings and close contact with recognized key opinion leaders in autism disorder area.
- Analyze business/market/competitor trends and customer needs and supports the commercial team to translate into innovative marketing programs to maximize business success.
- Responsible for developing the specific customer market and referring physician strategies to penetrate the market.
- Will help lead key launch initiatives in the US for Seaside’s first approved drug, for the treatment of Fragile X Syndrome.
- Responsible for developing the specific customer market and referring physician strategies to penetrate the market.
- Develop and implement educational programs for internal business partners, especially with the commercial team on reimbursement and health policy issues.
- Identify business development opportunities as they relate to product profile requirements or enhancements.
- Investigate and support grant opportunities.
- Support business development activities.
Director- Quality Assurance
Seaside Therapeutics is creating new drug treatments to correct or improve the course of Fragile X Syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families.
Position Summary
The Director of Quality Assurance is responsible for the management and oversight of all aspects of quality programs. The position will also contribute in a direct way to our Regulatory activities as well. This position reports to the Vice President of Regulatory and Quality Affairs.
Experience and Education:
- BS degree preferred
- 8 years quality experience to include creation and maintenance of a quality system and vendor auditing in a GxP environment
- 2 years regulatory experience a plus
- Ability to think intuitively and problem solve
- Ability to be successful in a fast pace, small, start-up environment
- Able to manage shifting priorities
- Experience with common technical document format a plus
Responsibilities:
- Establish & maintain Quality System to include change control, vendor qualification, records management, equipment/process/computer validation, training and competency program and documentation, internal and external audits, SOPs, process improvement and change control
- Responsible for release of investigational drug product
- Provide GxP Training as needed
- Create and review quality agreements
- Review and approve batch records
- Perform quality review associated for applicable documentation
- Responsible for vendor audits
- Responsible for quality audits associated with regulatory submissions and clinical trials
- Manage daily quality systems activities
- Ensure compliance with applicable regulations and internal procedures
- Provide input on all quality related matters
- Responsible for internal inspection readiness as well vendors and sites
- Provide IND support, recording of meeting minutes, preparation for regulatory meetings
- Document and track regulatory commitments
- Prepare annual reports in support of regulatory submissions
|
