Stirling Q&R
Director/ Senior Director Clinical Programs
Stirling Q&R, San Jose, California, United States, 95199
Title:
Director / Senior Director Clinical ProgramsC ompany:
Confidential Health-Tech InnovatorLocation:
San Francisco Bay Area, CaliforniaAbout Our Client:Our client is a leading-edge health-tech company at the forefront of innovative clinical access programs. A relatively recent creation, their mission is to bridge the gap between promising investigational treatments and patients with serious conditions who cannot enroll in traditional clinical trials.Overview:Our client is seeking a seasoned and energetic Director/Senior Director of Clinical Programs to join its expanding team on our behalf. The ideal candidate will have a solid foundation in the administration of clinical research operations, preferably within a CRO environment. This individual will be responsible for and play a crucial role in leading an expanding portfolio of specialized clinical access programs.Responsibilities:Ensure the planning, implementation, and management of various clinical access programs across various therapeutic areas. Develop and maintain SOPs for program operations. Liaise with pharmaceutical partners in the design and execution of programs to align with their strategies in clinical development. Oversee the development of study protocols, informed consent forms, and other essential documents. Manage clinical sites, investigators, and other stakeholder relationships.Ensure adherence to regulatory requirements, including FDA regulations and ICH-GCP guidelines. Lead and mentor clinical project teams. Monitor program timelines, budgets, and resources to ensure effective execution. Analyze and report program metrics and outcomes. Contribute to business development by participating in client meetings and proposal development.QualificationsAdvanced degree in life sciences, healthcare, or related field; MD, PhD, PharmD preferredMinimum of 10 years relevant experience in clinical research with a minimum of 5 years leadership-level experienceDeep understanding of the processes for planning, executing, and managing clinical trials, FDA regulations, and ICH-GCP guidelinesStrong knowledge of special access programs and applicable regulationsProven expertise in the delivery and management of complicated clinical programsExcellent project management and organizational skillsExcellent communication and interpersonal skillsPrior work experience with CRO's or smaller pharma/ biotechsFamiliarity with clinical trial management systems and other relevant softwarePreferred QualificationsDirect experience with expanded access or other pre-approval access mechanismsNeurology, oncology, rare disease, or other relevant therapeutic area backgroundExperience with real-world data collection and analysis Knowledge of cost recovery models in clinical researchOur client is offering:Salary up to $240,000 plus equity as well as a comprehensive benefits packageOpportunity to make material difference in the lives of patientsFast-paced dynamic and innovative work environmentOpportunities for Professional Growth and DevelopmentFlexible Work Arrangements around San Fran busy traffic periodsWork Location and Schedule:This role will require 3-4 days of in-office presence per week in San Jose, CAHow To Apply:If you are a qualified candidate looking for this exciting opportunity, please submit your resume and cover letter with relevant experience to the contact information noted below. All applications will be received in strict confidence.Our client is an equal opportunities employer and embraces applications from all qualified individuals. They invite applications without regard to race, color, religious affiliation, gender, sexual orientation, gender identity or expression, age, nationality, marital status, ability, or veteran status.
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Director / Senior Director Clinical ProgramsC ompany:
Confidential Health-Tech InnovatorLocation:
San Francisco Bay Area, CaliforniaAbout Our Client:Our client is a leading-edge health-tech company at the forefront of innovative clinical access programs. A relatively recent creation, their mission is to bridge the gap between promising investigational treatments and patients with serious conditions who cannot enroll in traditional clinical trials.Overview:Our client is seeking a seasoned and energetic Director/Senior Director of Clinical Programs to join its expanding team on our behalf. The ideal candidate will have a solid foundation in the administration of clinical research operations, preferably within a CRO environment. This individual will be responsible for and play a crucial role in leading an expanding portfolio of specialized clinical access programs.Responsibilities:Ensure the planning, implementation, and management of various clinical access programs across various therapeutic areas. Develop and maintain SOPs for program operations. Liaise with pharmaceutical partners in the design and execution of programs to align with their strategies in clinical development. Oversee the development of study protocols, informed consent forms, and other essential documents. Manage clinical sites, investigators, and other stakeholder relationships.Ensure adherence to regulatory requirements, including FDA regulations and ICH-GCP guidelines. Lead and mentor clinical project teams. Monitor program timelines, budgets, and resources to ensure effective execution. Analyze and report program metrics and outcomes. Contribute to business development by participating in client meetings and proposal development.QualificationsAdvanced degree in life sciences, healthcare, or related field; MD, PhD, PharmD preferredMinimum of 10 years relevant experience in clinical research with a minimum of 5 years leadership-level experienceDeep understanding of the processes for planning, executing, and managing clinical trials, FDA regulations, and ICH-GCP guidelinesStrong knowledge of special access programs and applicable regulationsProven expertise in the delivery and management of complicated clinical programsExcellent project management and organizational skillsExcellent communication and interpersonal skillsPrior work experience with CRO's or smaller pharma/ biotechsFamiliarity with clinical trial management systems and other relevant softwarePreferred QualificationsDirect experience with expanded access or other pre-approval access mechanismsNeurology, oncology, rare disease, or other relevant therapeutic area backgroundExperience with real-world data collection and analysis Knowledge of cost recovery models in clinical researchOur client is offering:Salary up to $240,000 plus equity as well as a comprehensive benefits packageOpportunity to make material difference in the lives of patientsFast-paced dynamic and innovative work environmentOpportunities for Professional Growth and DevelopmentFlexible Work Arrangements around San Fran busy traffic periodsWork Location and Schedule:This role will require 3-4 days of in-office presence per week in San Jose, CAHow To Apply:If you are a qualified candidate looking for this exciting opportunity, please submit your resume and cover letter with relevant experience to the contact information noted below. All applications will be received in strict confidence.Our client is an equal opportunities employer and embraces applications from all qualified individuals. They invite applications without regard to race, color, religious affiliation, gender, sexual orientation, gender identity or expression, age, nationality, marital status, ability, or veteran status.
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