Planet Pharma
Regional Lead of Clinical Operations
Planet Pharma, South San Francisco, California, us, 94083
Job Description
Position Summary: Seeking a talented, experienced and highly motivated Regional Lead of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for the (regional) operational execution, oversight and management of one or more clinical trials from start-up through close out for early stage clinical programs. As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills and play a key role in clinical trial planning and execution. Job Description Responsibilities
Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision
In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit
Manage various clinical vendors to ensure that project and corporate goals are achieved on time and within budget
Contribute to development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)
Serve as subject matter expert (SME) on various company/department initiatives and participate in the development, review and implementation of departmental SOPs and processes
Fiscal and contracts management: oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates
Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT
Clinical data review of data listings and summary tables, including query generation
Site management (e.g., review of monitoring reports, recruitment, quality metrics) in collaboration with CRO
Participate in other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)
Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), as appropriate
Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines
Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation
Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials
Train investigators and site staff, vendors and team members on study protocol and trial conduct processes
Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews/QCs, as needed
Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed
May require occasional domestic and international travel
Perform other duties as assigned Qualifications
Bachelors in life sciences or related discipline with 6+ years of experience in clinical and drug development
Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines
Early phase oncology trial management experience preferred including precision medicine trials
Self-motivated and strive for continuous improvement and embrace innovative ideas in daily work
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
Detailed oriented and creative thinker with a passion for process optimization
Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company
Analyze and triage problems, prioritize accordingly, and propose solutions
Ability to travel as required (approximately 20%)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Position Summary: Seeking a talented, experienced and highly motivated Regional Lead of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for the (regional) operational execution, oversight and management of one or more clinical trials from start-up through close out for early stage clinical programs. As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills and play a key role in clinical trial planning and execution. Job Description Responsibilities
Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision
In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit
Manage various clinical vendors to ensure that project and corporate goals are achieved on time and within budget
Contribute to development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)
Serve as subject matter expert (SME) on various company/department initiatives and participate in the development, review and implementation of departmental SOPs and processes
Fiscal and contracts management: oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates
Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT
Clinical data review of data listings and summary tables, including query generation
Site management (e.g., review of monitoring reports, recruitment, quality metrics) in collaboration with CRO
Participate in other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)
Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), as appropriate
Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines
Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation
Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials
Train investigators and site staff, vendors and team members on study protocol and trial conduct processes
Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews/QCs, as needed
Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed
May require occasional domestic and international travel
Perform other duties as assigned Qualifications
Bachelors in life sciences or related discipline with 6+ years of experience in clinical and drug development
Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines
Early phase oncology trial management experience preferred including precision medicine trials
Self-motivated and strive for continuous improvement and embrace innovative ideas in daily work
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
Detailed oriented and creative thinker with a passion for process optimization
Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company
Analyze and triage problems, prioritize accordingly, and propose solutions
Ability to travel as required (approximately 20%)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.