New Position at Theralase [url=https://www.wowjobs.ca/posting/FdX4WnSZSM8HB6PECg3n6E5r2M-yycGnFsehyF6nJlpYFeP_OgYXbAxbHu4KGmc0?]Director of Clinical Development[/url]
Director of Clinical Development
Overview:
Theralase® Technologies Inc. (“Theralase® or “Company”) is a publicly traded Canadian federal corporation (TSXV: TLT; OTCQB: TLTFF) focused on the destruction of cancer, consisting of two primary divisions:
1) Drug Division – Preclinical research and clinical development of Photo Dynamic Compounds (“PDCs”) and the light and radiation systems that activate them to destroy various cancers, bacteria and viruses safely.
2) Device Division - Manufacturer and distributer of proprietary super-pulsed Cool Laser Therapy (“CLT”) medical lasers, primarily in Canada and the United States, for the treatment of knee pain, and in off-label use, treatment of numerous nerve, muscle and joint conditions. In addition, the Device Division designs and manufactures proprietary medical laser systems used to activate the PDCs in the Drug Division.
Additional information is available at www.theralase.com and www.sedar.com
Job Description:
The Director of Clinical Development (“DCD”) will work in the Drug Division and will be responsible for:
1) General management of the Company’s multiple oncology clinical studies; specifically: managing all Clinical Research Associates (“CRA”), Clinical Research Organizations (“CRO”) and external monitors in the implementation, coordination and management of Clinical Study Sites (“CSSs”) in the timely and accurate completion of all clinical procedures, assessments and supporting documentation, in compliance with the clinical protocol, Informed Consent Form (“ICF”) and regulatory requirements
2) Successful completion of multiple clinical studies (Phase I, II, III and IV) from concept to successful regulatory approval.
Requirements:
- University education with a Medical Degree (“MD”) specializing in: oncology, neurology or thoracic surgery (or equivalent) and/or Doctor of Philosophy (“PhD”) degree in: Clinical Research, Biology or Life Sciences (i.e.: biological science, pharmacology, pharmacy, biochemistry, physiology, toxicology), or equivalent
- Relevant postdoctoral experience in oncology
- Hands-on experience leading the strategic planning and overall general management of: CMs, CRAs, CSCs, CROs and external monitors, of all aspects of multiple clinical oncology (Phase I, II, III and IV) from concept to successful regulatory approval
· Extensive experience managing multiple oncology clinical studies with multiple CSSs
Minimum 10 years’ Experience in:
1) Responsible for the coordination, administration and general management of multiple CSSs through the following phases:
i) Clinical Protocol (“CP”) and Investigator’s Brochure (“IB”) review, compilation, publication and training, in conjunction with the Chief Scientific Officer (“CSO”) for submission to Health Canada (“HC”) and the Food and Drug Administration (“FDA”), then CSS Research Ethics Board (“REB”), pending approval for PI and CSS
ii) CSS and Principal Investigator (“PI”) identification, with accompanying completion of Non-Disclosure Agreements (“NDAs”)
iii) Clinical Research Agreement (“CRA”) negotiation and budget finalization
iv) Site Qualification Visit (“SQV”), Site Initiation Visit (“SIV”) and Close Our Visits (“COVs”)
v) Informed Consent Form (“ICF”), Electronic Data Capture (“EDC”) design, implementation and training
vi) Study Drug, Study Device and Study Procedure training for PI and all staff including, the pharmacy, study nurses, Clinical Research Associate (“CRA”) and Clinical Study Coordinator (“CSC”)
vii) Compilation, submission and defense of: Clinical Trial Application (“CTA”), Investigational Testing Authorization (“ITA”), Investigational New Drug (“IND”), Break Through Designation (“BTD”), Accelerated Approval (“AA”), Priority Review (“PR”) and New Drug Application (“NDA”) with Health Canada (“HC”) and the Food and Drug Administration (“FDA”)
viii) Administration and management of CSSs, during patient screening, enrollment, study treatment, assessment and EDC reporting
ix) Review and closing of all open queries in the EDC to ensure irrefutable clinical data integrity
x) Soft data review and hard data lock
xi) Biostatistical data analysis via external biostatical organization and electronic Common Technical Document (“eCTD”) format compilation and submission to HC and the FDA
xii) Successful and timely marketing regulatory approval of sponsored oncological clinical studies by HC and the FDA allowing commercialization
The DCD will be responsible for:
1) Successful and timely regulatory approval of sponsored oncological clinical studies by HC and the FDA
2) Strategic planning and overall general management of all aspects of multiple clinical oncology programs (Phase I, II, III and IV) from concept to successful regulatory approval
3) Daily administration and management of EDC to ensure irrefutable clinical data integrity; including: managing CSCs, CROs and external auditors
4) Weekly reporting of clinical study status, based on a review of the latest EDC clinical database (i.e.: safety, efficacy and pharmacokinetics, at various assessment time points) to senior management, with quarterly reports to the board of directors and press releases to corporate stakeholders through quarterly newsletters
To be successful, the DCD will ensure the irrefutable clinical data integrity to allow for a statistical and clinical significance determination by the biostatistical team for timely submission to HC and the FDA for marketing regulatory approval to allow commercialization
Duties and Responsibilities:
- In collaboration with PIs, CSSs, CSS coordinators, CRAs, CSCs, CROs, external monitors and Theralase® senior management, coordinate, administrate and provide general management for all aspects of multiple Theralase® sponsored clinical studies at multiple CSSs
- Review and provide updates to the CP, ICF and IB based on PI, Theralase® senior management and Research Ethics Board (“REB”) review
- Based on CP, ICF and IB updates, update, verify and validate the EDC and re-train all CSS, PI and CSS coordinators on any changes to the Study Drug, Study Device or Study Treatment
- Monitor the clinical study’s EDC database by analyzing any open queries (in-house or via audits conducted by CSC, CRA, CRO, regulatory authority and/or third-party auditing organization) with the responsible CRA to ensure their timely closure (within 2 weeks of data collection)
- Review and authorize updated versions of controlled Standard Operating Procedures (“SOPs”) and adhere to SOP Good Clinical Practices (“GCP”)
- Assist CSCs, PIs, CSSs and CSS coordinators to update and remain in compliance with the version-controlled CP and ICF
- Keep track of clinical study activities to assure compliance with the approved CP and with all related local, municipal, provincial, national, international International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) regulatory and institutional guidelines, rules and regulations
- Review and authorize digital e-training materials and review and approve tests for Study Drug, Study Device and Study Treatment training for all CSSs, PIs, CSS coordinators and external monitors
- Review and authorize e-training materials to mirror the version-controlled CP and ICF, as required
- Provide log-in credentials for e-training sessions to CSS, PIs, CSS coordinators and external auditors and for those individuals who do not fully understand the e-training materials, based on their test scores, work with the CRA to contact them to more succinctly address their misunderstandings
- Review and authorize timely completion of required updates to the EDC master program to comply with the latest CP with programming assistance provided by third-party CROs
- Monitor pending enrollment, enrolment, treatment and assessment status of patients at each CSS and timely completion of this clinical information in the EDC by the CSS coordinators
- Provide feedback to CSS, PIs CSS coordinators and CRAs regarding inconsistent or confusing EDC clinical data for clarification
- Review and authorize patient dropout / lost to follow-up / removal of informed consent patient details in EDC.
- Review and authorize CP updates and ICF, prior to implementation to ensure compliance with sample collection procedures and EDC data recordation
- Discuss and verify compliance of CP and ICF updates with CSSs, PIs and CSS coordinators
- Review and authorize clinical study-related documents and forms such as CP worksheets, Adverse Event (“AE”) reports, Institutional Review Board (“IRB”) / REB documents, procedural manuals and progress reports
- Review and authorize supply and re-supply of Study Drug, Study Device and Study Device consumables to all CSSs, as required
- In collaboration with third-party audit organizations, coordinate and ensure timely completion of SQV, SIV, CSS monitoring visits and COVs
- Review and authorize AEs to ensure that they are properly documented in the EDC and followed by the PI and the CSS coordinators for timely resolution
- Review and authorize Serious AEs (“SAEs”) to ensure that they are reported by the PI once confirmed by Theralase® and are reported per CP procedures and documents to the respective REBs, regulatory authorities and to other CSSs, as required
- Prepare and maintain the Trial Master File (“TMF”) and electronic TMF (“eTMF”) to ensure all clinical study related documentation is included and up to date (i.e.: PI CVs, training, Delegation of Authority (“DoA”) logs, variances and associated waivers to the clinical protocol, et cetera)
- Review and authorize all laboratory results and follow CP procedures and documents regarding abnormal results
- Review and authorize all potential patient enrollments to ensure compliance with the CP, and after reviewing and providing their assessment to senior management, report back the sponsor’s decision on enrollment to the CSS and PI
- Review and authorize the preparation, management and filing of all regulatory documents, required per CP procedures and documents
- Review and authorize all patient screening, treatment and assessment visits with CSSs to ensure CP procedures and documents are completed on a timely basis (within 2 weeks of data collection).
- Review and audit the accurate completion of electronic Case Report Forms (“eCRF”) by authorizing external monitors to attend at the CSS and compare the paper versions of the patient’s confidential medical records with the EDC
- Review and authorize the preparation and update of Theralase® internal spreadsheets on patient screening, study treatment, assessment status and study treatment success / failure analysis to provide senior management a weekly update of study performance to primary, secondary and tertiary clinical study objectives
- Update finance and senior management on study treatment completion for financial payment of CSS invoices
Skills and Qualifications Required:
- Proven ability to maintain the strict confidentiality of all clinical data and records
- Expert knowledge of CPs
- Review, authorize and publish training materials for CSSs, PIs, CSS coordinators and/or external monitors
- Research, analyze and summarize information from professional journals, technical procedures and/or governmental regulations to present that information in executive form for review by senior management
- Effectively, accurately and succinctly respond to questions from CSSs, PIs, CSS coordinators and/or external auditors in a timely manner
- In-depth Good Clinical Practice (“GCP”) training and knowledge of the drug development process and the regulatory submission requirements for US FDA, Health Canada and the European Medical Association (“EMA”)
- Able to travel to the USA and within Canada for 2 to 5 day pre-arranged business trips, as required
- Expert user in Microsoft environment (i.e.: Office, Excel, Outlook, Word, Power Point and Publisher)
- Excellent oral, written and presentation communication skills in the English language
- Impeccable writing style, able to be tailored to specific audiences, perfect grammar and diction, attention to detail
- Strong problem-solving skills with a proven ability to achieve strategic objectives
- Self-disciplined, self-motivated and professional in demeanor
- Polished individual who remains calm and focused under pressure and who rises to meet the challenge
- Deadline orientated with an ability to meet tight deadlines and able to manage vendors in the completion of various assignments
- Organized, with an ability to prioritize in a multi-tasking environment with excellent attention to detail and accuracy
- Enjoys working in a challenging and fast growth environment
- Demonstrated flexibility and adaptability with an ability to learn from past performance and implement strategies to improve performance and achieve strategic objectives on time
Compensation:
- $150,000 to $200,000 base, full-time salary, commensurate with experience
- Employee benefits and stock options (subject to board of director’s approval)
Please send your resume for review and consideration. Only candidates, who are being considered for the DCD position will be contacted.
Job Type: Full-time
Salary: $150,000.00-$200,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Extended health care
- On-site gym
- On-site parking
- Stock options
- Vision care
Schedule:
Ability to commute/relocate:
- East York, ON M4B 3G4: reliably commute or plan to relocate before starting work (required)
Work Location: In person