Director/Associate Director, Clinical Development

Avigen, located in beautiful Alameda, California(San Francisco Bay Area), is committed to providing physicians and theirpatients with innovative therapeutics for the treatment of serious, chronicneurological conditions. We are seeking an exceptional candidate for thefollowing:



 

Director/Associate Director,Clinical Development

 

 

PositionDescription

Reporting to the VicePresident of Clinical Development, this employeewill play a strategic rolewithin the company, taking responsibility forclinical development programs forpain and/or spasticity in Phases 1 to3.  S/he is expected to provide creativescientificinput to clinical trial design as well as to coordinate the overallexecutionof the project.

 

Key Tasks andResponsibilities:

Design andimplement clinical development plans for specific CNS compounds, according toagreed-to strategy and timelines. 

 

Lead or collaborate in thedesign of clinical trial protocols with inputand support from DiscoveryScientists, Clinical Operations Specialists,and Project Managers. Provide input to statistical analysis plans

 

Plan, direct, and manageinternal and external resources for all aspects of the clinical developmentprogram.  Typically, ongoing clinical trial oversightwould include: 

·Identifyingand planning an appropriate balance of internal and external resources forclinical development activities.

·Selectingand working with investigational sites, CROs, and other contractors 

·Beingresponsible for scientific oversight of clinical trials and serveas theprimary contact for investigational sites for questions relatingto theclinical trial protocols (e.g. subject eligibility for inclusionin the trial)

·Interpretingincoming data and study results for safety and efficacy 

·Trackingprogress in ongoing trials and updating relevant internal and external groupson a regular basis

Provide necessary andappropriate level of input to Clinical andRegulatory documents, includinginvestigator brochures, ICFs, DSMBcharters, protocol amendments, studyreports, annual reports, TPPs, andultimately NDAs and CTAs.



Education and Experience:

Advanced degree in biomedicalscience, MD or PhD preferred. Experiencein neurology, psychiatry, psychology, neuroscience, pain management oranesthesia. A solid academic researchbackground is preferred. Patient careexperience is also desirable.

 

The candidate must haveclinical development expertise and a minimum of2 years of experience in thepharmaceutical or biotechnology industry.Specific experience in pain and/or CNS drug development is desired. 

 

Experience in clinicaldevelopment planning is required, as is asuccessful track record in the designand execution of clinical trials. Inadditionto familiarity with the processes of clinical site selection andinitiation,study monitoring, adverse event tracking and reporting, anddata management, abasic understanding of statistical concepts andapplications is required. A working knowledge of, and a commitment toadhere to, FDA regulations, GCP, ICH guidance, SOPs, and IRB requirements isexpected. 

 

The ideal candidate will havedemonstrated her/his ability to driveprograms to their successful completionin accordance with realistictimelines, budgets, and quality of data. 

 

Personal Attributes andAbilities:

·Unassailableprofessional integrity.

·An analytic and astrategic thinker, possessing flexibility of thought and a facility forcreative problem-solving.

·Excellentinterpersonal, leadership, negotiating, and influencing skills.

·Ability to drivea strategic agenda, but also deliver operationally.

·Highly developedverbal and written communication skills, with theability to synthesize andpresent complex data clearly, concisely, andlogically.  

·Ability tointegrate inputs both from the pre-clinical science and the commercial ends ofthe business. 

·Ability to thrivein a vigorous and independent-thinking, but overall supportive, culture. 

 

Company Culture andBenefits:

The culture at Avigen is oneof encouraging creativity and intellectualcuriosity.  The atmosphere isinformal yet productive with a strongcommitment to achievement. There is also a sense ofdedication to thepatient populations that will be served by Avigenproducts.  The companystrives to be highly people-oriented andsenior management is readilyaccessible. Open communication isexpected. 

 

Avigen is, and will remain, alean organization. Assuch, allemployees are challenged to operate beyond the classicalboundaries of theirjob descriptions as these might be defined in largeror more traditional pharmaceuticalcompanies.

Our employees are expected to make unique and valuedcontributions andwe appreciate them for their individual and collectiveeffort. Avigenhas all the benefits you would expect to find from a greatemployer and,as an added bonus, the company pays for all the benefits - ouremployeesmake no contributions from their checks: Ten paid holidays Two flexible days Paid Vacation - Three weeks Medical dental and vision Insurance Short and Long Term Disability Paid sick days Life, AD&D, and long term care insurance 401K Plan with company match Employee Assistance Program Stock Options 529 College Savings Plan Flexible Spending Accounts Domestic partner benefits  

To apply, email/send/fax resume to: Avigen, Inc.,Human Resources, 1301 Harbor BayParkway, Alameda, CA 94502;e-mail: hr@avigen.com , fax: (510)748-7371. EOE - Principals Only - NoPhone Calls.