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location: San Diego, California
job type: Contract
salary: $54.96 - 64.66 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- The Clinician is responsible for working collaboratively with the members of the development team (including a medically qualified individual) to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan.
- This job role does require individual to be medically qualified.
- Depending on experience, may contribute to or be primarily responsible for formulation of clinical development plans. Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.
- Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead or medically qualified individual. The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and SAF09 SOP (pharmacovigilance).
- May contribute to or be primarily responsible for Go-No recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition and preparation to Phase III.
- In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills.
- Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators.
- In conjunction with study team is responsible for the on-time and within-budget execution of protocols.
- May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.
- May act as clinical representative in in-licensing activities such as due diligence reviews and reports.
- May transition early development clinical programs into late stage development
- Demonstrated experience with GCP and the ability to apply company policies and SOPs
- This position reports into a Global Clinical Lead (MD Clinician).
- This position works in a matrix organizational structure with a variety of functional clinical development disciplines (Clinical Pharmacology, Translational Oncology, Clinical Operations, Statistics, Regulatory, Legal, Data Management, Programming, etc. ) to develop and execute a clinical study and also to close out and report on the trial.
qualifications: Education & Qualifications
- Degree in life sciences; Advanced scientific preferred (PhD, PharmD, MA); demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills
- 10 years in oncology clinical development, preferably in early development
- Demonstrated experience in writing clinical trials, developing clinical programs, executing clinical programs and reporting out clinical programs in the oncology therapeutic area (solid tumors/hematology)
- Demonstrated experience in early oncology clinical development.
- Ability to work in a matrix organizational structure.
- Ability to work in a fast-paced environment.
- Drug Development Skills - demonstrated experience in a clinical development environment, understanding and adherence to GCPs, SOP, and other international guidances.
- Business Acumen - - knows how businesses work; knowledgeable in current and possible policies, practices, trends and developments affecting our business and organization. Empowered to make observations and recommendations to establish a more efficient working environment
skills: SOP, GCP (Good Clinical Practice), Drug Safety
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.