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Scientific Positions
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Administrative Positions
Senior Director of Pharmacovigilance and Clinical Safety
(Ref # DRDS0413RM)
The Senior Director of Pharmacovigilance and Clinical Safety provides strategic leadership, oversight and management of pharmacovigilance and clinical safety. The position reports to the Exec VP Development and Chief Medical Officer.
Experience and Education Qualifications:
- M.D. required with at least 2 years of clinical experience post-qualification
- At least 10 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
- Pre- and post-approval experience
- Understanding of US and EU drug safety and pharmacovigilance requirements
- Experience of managing change
- General medical/therapeutic area knowledge
- Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
- Ability to influence while maintaining independent and objective views
- Excellent communication, interpersonal and organizational skills
- Attention to detail
- Delivery focused
- Good leadership qualities and ability to summarize and communicate clinical issues to a lay audience.
- Skilled in collaborative working relationships
- Proficiency with pharmacovigilance systems and computerized programs
- Proficiency in compiling and writing NDA documents (ISS)
Sr. Director/Director of Medical Affairs
(Ref# DRMA0413RM)
The Company is looking for an experienced Medical Affairs professional to occupy a leadership role, reporting to the EVP, Development and Chief Medical Officer. The Sr. Director/Director, Medical Affairs is responsible for providing strategic and medical oversight for marketed products as well as products under late phase of development (IIIb/IV).
Experience and Education Qualifications:
- MD/Pharm D with 10+ years' experience within the pharmaceutical industry is required
- Successful track record of leading and building a medical affairs department.
- Knowledge of the regulatory framework for approval and post-marketing commercial activities (FDA, DDMAC)
- Experience with literature information databases
- Strong verbal and written communication skills at a professional medical level.
- Management and supervisory experience (minimum 5 years) including experience with contractors and medical information service providers
- Leadership, coaching and mentoring skills
- Ability to manage budgets, multiple projects, and timelines
- Ability to collaborate cross-functionally across teams and across the organization (clinical, development, commercial)
- US and Ex US pharmaceutical experience from pre-launch through commercial/development lifecycle
- Experience of supporting product launches
- Publication and manuscript preparation experience
- Full understanding of all stages of pharmaceutical drug development process
- Neurology experience desired
Director, Data Management
(Ref# DRDM0413RM)
The Company is looking for an experienced clinical data management professional to occupy a leadership role, reporting to the EVP, Development and Chief Medical Officer. The candidate will assure operational excellence and leadership within Data Management in a growing organization. He/she will determine the resources that are required to manage the group, meet corporate objectives, and ensure that the data management systems are business ready and of appropriate quality to fulfill those objectives.
Experience and Education Qualifications:
- Masters, BA/BS degree or equivalent in a scientific or health care field preferred
- Minimum of 10 years' experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting
- Management experience, at least 5 years
- Knowledge of medical terminology required
- Knowledge of coding dictionaries (MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency in MS Office applications
- Proficiency with data management systems and supporting statistical programs (e.g., SAS)
- Knowledge of database design and database concepts
- The candidate will have either led a data management group or had experience as the data management lead, through a successful NDA/MAA.
Senior Director/Director, CMC Regulatory Affairs
(Ref# DRCMC0413HW)
The Senior Director/Director of CMC Regulatory Affairs provides regulatory leadership in support of the development programs at ACADIA and is responsible for the regulatory aspects of the CMC development for small molecules. The successful candidate will provide strategic guidance for global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products. This person represents the regulatory function on multi-disciplinary CMC product development teams and with external entities. The person in this role serves as a resource to CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through to the initial marketing application, and life cycle management.
Experience and Education Qualifications:
- A bachelor's degree in a life science, additional consideration will be given for applicants with an advanced degree in chemistry or associated science.
- At least 8 years of CMC regulatory affairs experience; small molecule experience required
- Knowledge and understanding of U.S. as well as global regulatory regulations and guidelines
- Previous experience in the preparation and submission of the CMC components of IND/CTA/as well as NDA/MAAs
- Ability to work in a cross-functional team environment and manage competing priorities
- Strong interpersonal skills, attention to detail and excellent organizational, computer, and documentation skills
Associate Director/Director of Regulatory Archives and Operations
(Ref# DRRAO0413HW)
The Associate Director/Director of Regulatory Archives and Operations will be responsible for the oversight of all regulatory archival and operational activities necessary to ensure the successful preparation and filing of regulatory submissions. This individual will establish standards and oversee document collection, publication and archival to assure timely and quality regulatory submissions. This individual will establish electronic publishing and archival systems necessary to produce a high-quality NDA in eCTD format and will act as the primary liaison with publishing vendors to ensure delivery of submissions according to established guidelines and timelines.
Experience and Education Qualifications:
- BA/BS, preferably in a scientific discipline; 6-8 years Regulatory Affairs experience with document archiving and electronic publishing experience
- Understanding of all ICH and FDA guidance relevant to electronic regulatory submissions
- Experience and knowledge in the preparation of global regulatory submissions (including original IND/IND amendments, CTAs, NDA/BLA/MAA)
- Late stage drug development and NDA experience highly desirable
- Ability to work in a cross-functional team environment and manage competing priorities
- Experience with an electronic document management system and/or workflows
- Experience and knowledge of eCTD and publishing tools (ISIToolbox Pharma Edition)
- Experience working with vendors on publishing deliverables under critical timelines
- Experience working in a team environment
- Ability to work both independently with direction and within project teams and see all projects through to their completion
- Excellent verbal and written communication skills are essential
- Strong organizational skills, including the ability to prioritize workload
- Strong interpersonal skills and the ability to deal effectively with other people/departments
- Experience in record keeping and document organization in a setting where controlled documents are used
- Ability to meet deadlines and perform multiple tasks in a fast paced setting