SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Clinical Study Manager/Associate Director

Company: Ambrx, Inc.
Location: La Jolla
Posted on: September 15, 2019

Job Description:

Ambrx is a clinical-stage biopharmaceutical company with a mission to deliver breakthrough protein therapeutics through our proprietary technology. Unlike conventional conjugation technologies that creates a mixture of suboptimal molecules, Ambrx technology incorporates non-natural amino acids beyond the common twenty into the protein biosynthesis, enabling site specific conjugation of payloads, pharmacokinetic extenders with proteins to create novel homogenous molecular species that is optimized for safety, efficacy and biophysical properties. Ambrx is seeking a highly motivated Clinical Study Manager/Associate Director to be a key member of the clinical team in a fast-paced and dynamic environment. This position will be responsible for planning, initiating and executing clinical studies with a focus on operational excellence and regulatory compliance. Major Responsibilities: Oversee all operational aspects of assigned clinical trials, drive excellence in clinical operations to ensure compliance with regulatory and GCP requirements to attain high quality and efficient clinical conduct and achieve established goals within timelines and budget Develop and execute study materials, such as, protocol, ICF, CRFs, study monitoring plans, pharmacy manuals, site initiation presentation deck, site management plans, data management plan, and protocol deviation management plan, etc. Play a key role in clinical CROs/vendors selection, budget negotiation and contract approval for clinical programs at different development stages according to regulatory guidance and internal SOPs. Work with QA, Legal and Finance to ensure assumptions, scope, vendor responsibilities, and payment terms are clearly defined. Manage CRO and central lab activities, monitor study conduct closely to ensure GCP compliance and milestone deliverables. Review CRA monitoring reports, proactively identify and timely address any potential concerns and issues. Prepare regular status updates to senior executives. Plan and conduct internal and external meetings such as cross function team meetings, corporate updates, SMC meetings, investigator meetings and KOL meetings, etc. Job Qualifications: BS or MS or Ph.D. in a biological science related field. 10+ years of relevant experience in the clinical trial monitoring and management Excellent English written and verbal communication skills Strong interpersonal skills with an ability to confidently interact with key internal and external stake holders including department heads, senior management, physicians, administrators, and consultants Successful track record in managing phase 1-3 clinical studies Proven organizational and collaborative skills essential Prior experience in conducting MRCT is a plus Willing to travel up to 15% for SIV, co-monitoring, and coordinating investigator meetings Must be self-motivated, detail-oriented, results driven and able to work effectively in a fast-paced environment with minimal supervision To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.

Keywords: Ambrx, Inc., San Diego , Clinical Study Manager/Associate Director, Other , La Jolla, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Now Hiring: FedEx
Description: Easy Application
Company: FedEx.FindDreamJobs.com
Location: La Quinta
Posted on: 09/19/2019

Family Med or Internal Med
Description: Required skills experience the 5 must haves to be considered 1. MUST be Board Certified 2. Must have a California medical license OR be willing to attain one 3. Must have DEA 4. Must
Company: Relode
Location: Calexico
Posted on: 09/19/2019

Fragrance Specialist
Description: The Fragrance Specialist
Company: AllWork
Location: Palm Desert
Posted on: 09/19/2019


Dog Sitter - Work from Home, Earn up to $1,000/month
Description: Want to make money watching dogs at home or around your neighborhood We're looking for animal lovers like you to join Rover as independent pet sitters. Set your own schedule: Full time, part time-work (more...)
Company: Rover
Location: Calexico
Posted on: 09/19/2019

Dog Sitter - Flexible Hours, Work From Home, Play With Dogs
Description: Want to make money watching dogs at home or around your neighborhood We're looking for animal lovers like you to join Rover as independent pet sitters. Set your own schedule: Full time, part time-work (more...)
Company: Rover
Location: El Centro
Posted on: 09/19/2019

Infantryman - Management Training (11B)
Description: 11B Infantryman - Management Training Job ID: 1102024 Job Views: 192 Location: COLTON, California, United States ZIP Code: 92324 Job Category: Ground Forces Posted: 09.04.2019 Age Requirements: (more...)
Company: Army National Guard
Location: Colton
Posted on: 09/19/2019

Get New Landscaping Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: El Centro
Posted on: 09/19/2019

Insurance Specialist I
Description: Teamwork. Integrity. Dedication. Together, we make a difference. If you are a career-minded, service-driven professional looking to join a fast paced organization then you have come to the right place.AAA (more...)
Company: Auto Club of Southern California
Location: La Quinta
Posted on: 09/19/2019

Dog Sitter - Work from Home, Earn up to $1,000/month
Description: Want to make money watching dogs at home or around your neighborhood We're looking for animal lovers like you to join Rover as independent pet sitters. Set your own schedule: Full time, part time-work (more...)
Company: Rover
Location: El Centro
Posted on: 09/19/2019

Hair Stylist
Description: Description: br One of the busiest salons in Yucaipa now has an opening for a full-time or part-time hair stylist. Why pay booth rent or take years to build your clientele as an independent contractor (more...)
Company: VSTYLES INC
Location: Yucaipa
Posted on: 09/19/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds