Job Postings
San Diego Opportunities
Scientific Positions
Development Positions
Associate Director/Director, Regulatory Affairs
(Ref # AD/DRA0512HW)
The successful candidate will lead regulatory activities in support of product development, develop regulatory plans supporting the approval of candidate products, and actively participate in drug development project teams. They will lead successful interactions with regulatory agencies, including preparation of regulatory correspondence, applications and meetings. They will ensure compliance with applicable drug development regulations.
Experience Qualifications:
- Preferably 7+ years relevant experience in drug development
- Experience with preparation and maintenance of US INDs and marketing applications
- Experience with international clinical trial and marketing authorization applications
- Strong communication skills (verbal, written, listening)
- Effective interpersonal skills and ability to successfully and accurately communicate with multiple disciplines (internally and externally, e.g., FDA and international regulatory authorities)
- Strong leadership and mentoring skills; team oriented; excellent time management skills; detail oriented
- Ability to communicate with colleagues from scientific, medical and manufacturing disciples
The successful candidate must also have either a Bachelor of Arts or Science degree, preferably in a scientific discipline or the equivalent.
Clinical Program Manager / Associate Director (2 positions available)
(Ref # CPM/AD0412RM)
The successful candidate will be responsible for ensuring that the clinical programs for ACADIA projects are executed effectively. This will include oversight, management and guidance of clinical trials. A critical component of the role will be to ensure quality delivery of goals and study enrollment within agreed budgets and timelines. The individual will be required to work with project leaders to ensure that appropriate resources and information are available in order that project goals are met. The individual must develop working relationships with internal team members, external vendors and clinical site staff. The individual must effectively communicate project status and issues to management and the team, and proactively anticipate obstacles and risks and devise and implement solutions. The individual will be required to develop clinical protocols, Clinical Study Reports, and other documents relevant to support the development program and NDA's. Well-developed skills to select CRO's and manage these external resources effectively are a requirement.
Experience Qualifications required are as follows:
- 10 years relevant clinical experience
- Experience managing staff
- Excellent interpersonal skills and demonstrated ability to lead
- Adaptability to changing priorities
- Strong communication and organizational skills
- Experience developing protocols, SOP's and Clinical Study Reports
- Demonstrated ability to successfully develop, implement, manage and complete clinical trials
The successful candidate must also have either a Bachelor of Arts or Science degree, preferably in a scientific discipline or the equivalent.
Administrative Positions