Career Openings

Thank you for your interest in TP Therapeutics (TP).  TP is a clinical-stage structure-based drug design company for the discovery and development of precision medicines for cancer and other diseases.  We are focusing on the design of novel chemical identities for established oncogene drivers with secondary resistant mutations, newly identified disease-driven targets, and potential targets regulating tumor microenvironment and tumor immunity.  

Controller

The Role
Reporting to the Vice President, Finance, TP Therapeutics is seeking a Corporate Controller located in San Diego, CA. ​This position is a leadership role that will be responsible for the accounting function, including oversight of the financial close process, external financial reporting, accounts payable, payroll, stock plan administration, Sarbanes-Oxley compliance, tax, accounting systems and direct management of audit engagements, amongst other responsibilities.

Specific areas of responsibility will include:

  • Management of the monthly/quarterly accounting close
  • Managing and mentoring members of the accounting team
  • Oversee the preparation and review of GAAP financial statements for internal and external reporting
  • Oversight of SEC filings including stock offerings, quarterly 10Q’s, annual 10K’s, proxies and other SEC forms as periodically filed
  • Provide technical accounting support and research for advanced GAAP or SEC topics (may involve the oversight of external resources as well)
  • Serve as primary coordinator for auditor engagements
  • Provide oversight and management of stock plan administration and accounting
  • Oversight of payroll function and partnering with HR to manage employee benefits
  • Serve as primary lead for establishing Sarbanes-Oxley 404 compliance
  • Interface with external tax advisor on relevant tax matters
  • Oversee implementation of accounting and other finance systems
  • Work with the Vice President, Finance to manage and grow capabilities of the Finance department
  • Participate in or manage special projects from time to time
  • Other accounting and finance duties as required

Required Education, Skills and Experience

  • Bachelor’s degree in accounting, finance or business administration
  • CPA
  • 8+ years of experience in accounting operations, financial reporting; 2+ years as a Sr. Accounting Manager, Assistant Controller or Controller
  • Prior experience working in a life science company
  • Demonstrable experience managing the monthly/quarterly accounting close process at a public company
  • Strong experience supporting and leading annual financial audits and quarterly reviews
  • Previous experience managing Sarbanes-Oxley compliance
  • Proven history and experience successfully managing others including clear demonstration of strong leadership, team building and employee development skills
  • Strong communication/writing skills and history of effectively interfacing with all levels of management
  • Must be a kind, respectful, fair, trustworthy, and dependable team member and leader

Preferred Skills and Experience

  • Equity Edge and ERP system implementation/conversion
  • Previous Big 4 audit experience

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Vice President, Clinical Development (MD Required)

ROLE SUMMARY

  • Oversee execution of early and late clinical development strategies
  • Development spans pre-IND, First in patient through Approval and Commercialization.
  • Work collaboratively with multiple internal groups to develop clinical development plans.
  • Collaborate with the Senior Management and other line function heads to help streamline asset development plans and to lead clinical development teams.
  • Work collaboratively with other line function heads to drive early Candidate Selection of early pipeline assets and establish best path forward for their INDs and development plans.
  • Oversee and mentor medical monitors within the organization, and potentially other internal functions (depending on qualifications and desires)
  • This position will report into the EVP, Chief Medical Officer and be a key member of the clinical organization

ROLE RESPONSIBILITIES

  • Develop innovative clinical development plans that drive early decision making based upon objective clinical safety and efficacy response measures.
  • Work collaboratively to develop expedited Proof of Concept programs that lead to seamless late stage development.
  • Collaborate with external experts to drive innovation in early and late clinical development plans and translational/precision medicine.
  • Represent TP Therapeutics at critical regulatory interactions.
  • Ensure highest level of rigor and scientific integrity of clinical programs and protocols.
  • Function as the Team Leader for at least one clinical asset and work in partnership with other team Leader(s) to ensure delivery of high-quality, cost-effective programs that are delivered on time and within budget, while maintaining the necessary resources needed to deliver the program.
  • Meet regularly with senior leaders, including Chief Medical Officer
  • Identify and escalate issues in a timely manner as appropriate.
  • Meet with Senior Management as requested to keep them fully informed of issues of high priority related to Oncology.

QUALIFICATIONS

  • MD, MD/PhD or equivalent with extensive clinical experience.
  • At least 10 years of oncology development experience within the Biotech or Pharmaceuticals industry, with focus in early development in Oncology (preferred).
  • Ability to collaborate across multiple functions within the organization
  • Ability to lead in a team environment.
  • Understanding of the drug development continuum from pre-POC to post-POC and commercialization.
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
  • Demonstrated scientific productivity (publications, abstracts, etc.).
  • A thorough understanding of Oncology and cancer biology and its relationship to drug development.
  • Experience in functioning effectively as a member of a multidisciplinary team.
  • Insight into and understanding of principles related to evaluating business deal structures including commercial collaborations, acquisitions, and divestitures.
  • Experience in budgetary management and decision making.
  • Demonstrated effectiveness in people management, communication and colleague development.
  • Demonstrated effective negotiating, influencing, interpersonal and leadership skills.
  • Exceptional verbal and written communication and presentation skills.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Sr.Director/Director, Clinical Operations

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Sr. Director/Director, Clinical Operations reporting into the VP of Clinical Operations.  The Sr. Director/Director, Clinical Operations will support the clinical development programs for the investigational lead drug candidates in company sponsored and/or investigator-sponsored trials.

As a key member of the Clinical Operations team, the successful candidate will work closely with the Vice President of Clinical Operations and will provide leadership, project management, and oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions.

This position also provides an opportunity to join a growing organization and contribute substantially to how the company will operationalize oncology trials in the future. In addition, there is an opportunity to expand your knowledge through day-to-day activities and close interactions with the Medical, Translational Sciences, Research and Discovery teams within TP Therapeutics.

ROLE RESPONSIBILITIES

  • Align with the VP of Clinical Operations on strategy for successful implementation and execution of TP Therapeutics clinical trials
  • Manages and drives excellence in the overall clinical operational activities for multiple clinical trials. Also responsible for CRO selection, efficiencies and oversight, to ensure quality conduct of trials and data integrity.
  • Provides functional expertise for Clin Ops strategies and tactical implementation of the studies by managing timelines, deliverables, budget forecasting, etc.
  • Oversees the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management, site/country selection, etc.
  • Consistent with Safety Management Plan (SMP), performs and documents regular review of individual subject safety data and performs review of cumulative safety data in collaboration with the Medical Monitor
  • Develops a Data Management Plan (DMP) with CRO and cross functional team members within Medical, Data Management and Statistics
  • Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution
  • Provide Senior Management with timely updates on progress (including any changes in scope, schedule, and resources across the program)
  • Depending on experience may contribute to or may independently design protocols and/or amendments
  • Depending on experience, may contribute to or be primarily responsible for formulation of a Clinical Development Plan (CDP)
  • Develops site recruitment, enrollment and engagement strategies for all clinical trials
  • Collaborates with cross functional team members to prepare strategy presentations, present and discuss data at relevant meetings, external consultants, KOLs and potentially regulatory meetings as well as author sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills
  • Ensures effective communications to internal and external stakeholders through meetings, presentations, and other methods. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
  • Participates in resource prioritization to ensure department and corporate goals and milestones are achieved
  • Collaborates with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits
  • May hold line management responsibilities, including hiring talent, performance development, and mentoring
  • Influences and leads ClinOps and cross functional team members to deliver quality results in a timely manner
  • Demonstrates experience with GCP and the ability to develop and apply internal policies and SOPs. Evaluates, recommends, and presents standard practices and process improvements for TPT clinical trial implementation

QUALIFICATIONS

  • Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred.
  • Director: B.A/B.S. plus 10+ years in relevant experience or Advanced degree and 7+ years relevant experience
  • Director: B.A/B.S. plus 15+ years in relevant experience or Advanced degree and 12+ years relevant experience
  • Experience considered relevant includes clinical or basic research in a Biotech, Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
  • Demonstrated experience in oncology drug development; familiarity with related disciplines (biostatistics, regulatory, data management, safety, QA)
  • Excellent organizational and leadership skills with strong experience in executing all phases of clinical trials
  • Demonstrated scientific writing and strong communication skills
  • Some travel may be required; approximately 20% travel

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Senior Clinical Trial Manager

ROLE SUMMARY

  • We are seeking a highly motivated individual to join TP Therapeutics as a Senior Clinical Trial Manager (CTM), Clinical Operations reporting into the VP of Clinical Operations. The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. The CTM ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational, communication, and leadership skills, with strong experience in executing all phases of clinical trials

ROLE RESPONSIBILITIES
• Drives all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
• Drive and oversees project timelines, CRO and vendor performance to meet departmental and corporate goals.
• Ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
• CRO Selection: Solicit and review proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
• CRO/Vendor Management: Communication/oversight of Vendors/CROs, primary point of contact for questions; follow up on issues or outstanding items. Resolve issues and escalate to management as needed.
• CRO Oversight: Efficiently work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs.
• Site selection/Visit report review: Review Qualification Visits as a priority and inform CRO whether site is approved for selection. Review Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
• Contract/Budget Oversight and Management: CTM will track spending of clinical trials against company budget. Review and approve invoices from vendors/consultants as per contract. Obtain executive team management approval of changes to contracts/budgets.
• Manage the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
• Medical Writing: Contribute to and/or author protocols, protocol amendments, clinical study reports, initial IND and annual IND updates, Investigators Brochure and updates, ICF etc.
• Data Monitoring Committee (DMC): Work with CRO/Vendor to select DMC members, develop the DMC Charter, obtain internal review of DMC documents and plan DMC meetings.
• Monitor study progress: Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRO CRAs as applicable.
• Plan and present at Investigator Meetings and/or Site and CRA trainings.
• Participates in study strategic development, Line Listing Review and Clinical Study Report preparation, as appropriate.
• Coordinate the oversight of sample collection, process and analysis (i.e., tissue samples, lab samples, scans, PK samples).
• Track and coordinate trial related materials, including study drug and other clinical trial supplies.
• Clinicaltrials.gov: Act as administrator for the Protocol Registration System (PRS) & get internal agreements for entries, register studies & submit results on PRS. Responsible for keeping information updated for ongoing clinical trials.
• Participate in risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle
• Perform periodic reviews and QC of the Trial Master File.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Serve as a liaison and resource for investigational sites.
• Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
• Travel as required to carry out responsibilities.
• Organize and manage internal team meetings and other trial-specific meetings.
• Participate in the development, review and implementation of departmental SOPs and processes.

QUALIFICATIONS
• Bachelors in a scientific or health care field is required
• Minimum of 5-7 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
• Experience in managing oncology clinical trials and/or orphan disease indications preferred.
• Someone with biotech or pharmaceutical experience as an in-house CTM for 3+ years
• Clinical operations experience at a small or mid-size company
• Experience in running a trial from start to finish; protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out
• Developed leadership skills to manage a clinical study team
• Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities
• Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
• A strong communicator with excellent verbal and written communication skills
• A highly collaborative person who is able to respond to changing circumstances and needs
• Ability to travel up to approximately 20-25%.

EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Trial Manager

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Trial Manager (CTM), Clinical Operations reporting into the VP of Clinical Operations.  The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. The CTM ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational, communication, and leadership skills, with strong experience in executing all phases of clinical trials

 

ROLE RESPONSIBILITIES

  • Drives all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
  • Oversees project timelines, CRO and vendor performance to meet departmental and corporate goals.
  • Ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
  • CRO Selection: Solicit and review proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
  • CRO/Vendor Management: Daily communication/oversight of Vendors/CROs, primary point of contact for questions; follow up on issues or outstanding items. Resolve issues and escalate to management as needed.
  • CRO Oversight: Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs.
  • Site selection/Visit report review: Review Qualification Visits as a priority and inform CRO whether site is approved for selection. Review Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
  • Contract/Budget Oversight and Management: CTM will track spending of clinical trials against company budget. Review and approve invoices from vendors/consultants as per contract. Obtain executive team management approval of changes to contracts/budgets.
  • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
  • Medical Writing: Contribute to and/or author protocols, protocol amendments, clinical study reports, initial IND and annual IND updates, Investigators Brochure and updates, ICF etc.
  • Data Monitoring Committee (DMC): Work with CRO/Vendor to select DMC members, develop the DMC Charter, obtain internal review of DMC documents and plan DMC meetings.
  • Monitor study progress: Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRO CRAs as applicable.
  • Coordinate/plan Investigator Meetings and/or Site and CRA trainings.
  • Participates in study strategic development, Line Listing Review and Clinical Study Report preparation, as appropriate.
  • Coordinate the oversight of sample collection, process and analysis (i.e., tissue samples, lab samples, scans, PK samples).
  • Track and coordinate trial related materials, including study drug and other clinical trial supplies
  • Perform periodic reviews and QC of the Trial Master File.
  • Identify potential study issues and recommend and implement solutions or corrective actions as needed.
  • Serve as a liaison and resource for investigational sites.
  • Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
  • Travel as required to carry out responsibilities.
  • Organize and manage internal team meetings and other trial-specific meetings.
  • Participate in the development, review and implementation of departmental SOPs and processes.

 

QUALIFICATIONS

  • Bachelors in a scientific or health care field is required
  • Minimum of 3-5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
  • Experience in managing oncology clinical trials and/or orphan disease indications preferred.
  • Someone with biotech or pharmaceutical experience as an in-house CTM
  • Clinical operations experience at a small or mid-size company
  • Experience in running a trial from start to finish; protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out
  • Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities
  • Strong knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
  • A strong communicator with excellent verbal and written communication skills
  • A highly collaborative person who is able to respond to changing circumstances and needs
  • Ability to travel up to approximately 20-25%.

 

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Director/Senior Director of Clinical Development MD

ROLE SUMMARY

  • To develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
  • To work collaboratively with the functional groups within Oncology Clinical Development.  
  • To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials. 
  • To support projects from Research to Proof of Concept (typically phase 2).  To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.

ROLE RESPONSIBILITIES

  • Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan, and regulatory documents.
  • He/she will closely work in a team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others. The candidate will work on clinical projects and will support the development and provide consultation regarding multiple research projects.
  • Provide administrative and technical oversight of clinical function within his/her Group
  • Ensure that all activities are conducted in compliance with relevant regulatory requirements.
  • Monitor and report on implementation of clinical initiatives in his/her group
  • Develop charters, resource utilization and project plans to achieve clinical project specific goals
  • Implement site organizational design and develop succession planning for clinical area.
  • Develop people, including recruitment, retention, and career development as directed by management.
  • Ensures development of and adherence to a Safety Review Plan (SRP).  Consistent with the SRP, performs regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. As appropriate, the Senior Director may delegate these responsibilities to a physician study clinician identified in the SRP.
  • Be accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.
  • Implement strategies to ensure that the clinicians are collaborative, strategic partners with scientific and clinical colleagues.
  • Implement strategies to ensure appropriate consistent processes in strong collaboration with partners.
  • Develop effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations.
  • Implement aligned strategies and consistent processes to optimize the use of corporate standards

QUALIFICATIONS

  • Requires MD/PhD or MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting.
  • Prior specialized training in Medical Oncology; Board Certification in Oncology is desirable
  • At least 3 or more years’ experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept.
  • Experience in the development of therapeutics in Oncology
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). 
  • Demonstrated scientific productivity (publications, abstracts, etc.)
  • Proven scientific writing skills and good communication skills
  • Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
  • Capacity to adapt to a fast-paced and changing environment

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Executive Assistant

ROLE SUMMARY

  • The Executive Administrative Assistant position will provide administrative support to the senior executives of TP Therapeutics. This includes coordination of daily schedules, meetings, agendas, presentations, travel arrangements, and expense reports for the executives. It will also include support and coordination for key members of the organization.
  • This is a demanding, high visibility role, and will interface with senior leaders inside and outside of TP Therapeutics.

ROLE RESPONSIBILITIES

  • The candidate must have excellent administrative, coordination, and communication skills and be capable of working independently.
  • Attention to detail is a must, as is the ability to maintain confidentiality.
  • The candidate will be working in a fast-paced environment.
  • Candidates should possess strong interpersonal skills, leadership, negotiation, analytical and problem-solving skills to support the needs of the executives and other team members.
  • Strong organizational skills are a must.
  • Advanced computer skills including word processing, spreadsheet, presentation and database software will be used every day.
  • This position requires full time presence on site, the ability to effectively multi-task and to solve problems within the scope of this role.

QUALIFICATIONS

  • A minimum of a High School diploma is required.
  • A Bachelor’s Degree is preferred.
  • A minimum of 6 (six) years of administrative or related experience is required.
  • Experience in an executive environment, supporting leaders and executives as well as their teams, is required.
  • Advanced computer skills (MS Office, including word processing, spreadsheet, presentation and database software) are required.
  • Experience with making international and domestic travel arrangements and coordinating on/offsite meetings are required.
  • Excellent verbal and written communication skills are required to properly draft and edit memorandums, correspondence and presentations and interface with senior leaders.
  • Organizational skills, exemplary stakeholder service skills, the ability to handle multiple tasks and priorities simultaneously, and the ability to work with independence and minimal supervision is required.
  • Demonstrated team player attitude, with a record of proactively taking initiative as appropriate is required.
  • Ability to handle confidential matters requiring discretion is required.
  • Demonstrated excellent judgment and the ability to solve problems proactively is required.
  • Acute attention to detail is required.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Data Manager

ROLE SUMMARY

  • The Clinical Data Monitor (CDM) is responsible for the clinical data review of one or more studies/programs, most often within a submission timeline.
  • The studies supported by the CDM are complex comparative safety and efficacy trials that are high-enrolling and require robust data capture.  In addition, the CDM ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications. 
  • Review tasks performed by the CDM include both point-to-point data checks and interpretive analysis.

ROLE RESPONSIBILITIES

  • The CDM will use data review best practices and associated data review tools to identify trends and any safety signals.
  • The CDM routinely provides functional management of studies and or compounds being reviewed.
  • The CDM will perform and coordinate the data review deliverables across studies and at the program level.
  • Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
  • Provides data review subject matter expertise support for studies, as needed, within Clinical Sciences group.

Qualifications

  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
  • Strong field monitoring experience an asset
  • Extensive Clinical Research experience, ideally on the side of the sponsor and with a track record of successful regulatory submissions
  • Strong background in Oncology
  • Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.
  • Familiar with database systems; technically competent with Microsoft Excel and ideally, Access.
  • Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.

QUALIFICATIONS

  • Bachelor’s degree in one of the disciplines related to life sciences, drug development or business.
  • Advanced degree is desirable.
  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
    • Some travel may be required

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Senior Medical Writer

ROLE SUMMARY

The Senior Medical Writer creates documents pertaining to clinical data to support product development and license applications in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization applications, and responses to clinical and safety questions from regulatory authorities.

ROLE RESPONSIBILITIES

  • Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
  • Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
  • Support project teams by providing analyses of clinical data.
  • Communicate position on resource and timeline needs for assigned documents to project team members, and keeping management informed.
  • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and management in a timely manner of any definite or potential deviations.
  • Drive document strategies and messages in a collaborative way with relevant project team. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
  • Deliver assigned documents on or before deadline, alerting project teams and management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
  • Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
  • Understand relationships and dependencies between documents and analyses produced for regulators.
  • Collaborate with project team, ensuring the accuracy and quality of information presented in assigned documents.
  • Identify potential areas for process improvements and possible solutions, and communicate these management.

QUALIFICATIONS
Education

  • Master’s degree or doctorate or qualification in life sciences preferred. Alternatively, bachelor’s degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.


Experience and Ability

  • BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the pharmaceutical or biotech industry with demonstrated experience leading the medical writing portion of regulatory submissions (NDAs and MAAs).
  • Able to interpret complex analyses of data supporting regulatory submissions.
  • Ability to serve as an authority on the interpretation of regulatory guidance and their significance in a broad range of situations.
  • Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies.
  • Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area.
  • Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses. Ability to make decisions by identifying innovative options or multiple solutions to complex problems.
  • Recommends courses of action to management and senior leaders that impact the discipline, department or line.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Associate Director, Regulatory Operations

ROLE SUMMARY

  • The Regulatory Operations Associate Director will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget. The position will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners. Emphasis will be on proper planning, management, and superior execution on all aspects of regulatory affairs operations.

ROLE RESPONSIBILITIES

Under direction from, and in collaboration with the Vice President, Regulatory Affairs, the Regulatory Operations Associate Director will:

  • Collaborate with teams to plan, create and submit original US INDs and amendments, original US NDAs, amendments and supplements, EU MAAs, Canadian NDS’, amendments and variations in eCTD format and ex-US clinical trial applications in electronic or paper formats, as required (formatting, publishing, submitting, life-cycling, and archiving sequences).
  • Oversee technical aspects for submissions (eg, eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities).
  • Serve as system owner for regulatory information tools and systems (eg, eCTD publishing tools, electronic document management system (EDMS), library system and electronic templates).
  •  Ensure that regulatory information tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.
  • Maintain expert knowledge of electronic submission and computerized system validation standards.
  • Identify potential risks to submission plans and propose risk mitigation strategies.
  • Ensure tracking and archiving of regulatory communications and submissions.
  • Support budgeting and forecasting for function and Regulatory Affairs department.
  • Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor)
  • Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities
  • Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team

QUALIFICATIONS

  • 5-7 years’ experience working in a Regulatory Operations environment with demonstrated ability to present and articulate requirements
  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
  • Experience managing EDMS, regulatory publishing systems, and tracking databases
  • Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint, and MS Project or Smartsheets
  • Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications
  • Demonstrated experience and a clear understanding of submission content and format requirements
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines
  • Solid experience administering and maintaining Regulatory document authoring templates
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills
  • Ability to apply knowledge to new situations.
  •  Minimal travel is to be expected, approximately 10%

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Scientist, Clinical Development

ROLE SUMMARY

  • Translate preclinical discoveries into viable oncology therapeutics by supporting clinical development trials and programs within TP Therapeutics’ portfolio
  • Support corporate strategy and clinical development department deliverables for clinical trials and programs by helping with design of scientifically sound clinical protocols and ensuring decision quality clinical data is being generated on an ongoing and timely basis
  • Support clinical development deliverables of determining and measuring optimal pharmacodynamic outputs and enhancing science based patient selection strategies
  • Support the program’s medical monitor/director in the design, conduct, and assessment of the clinical studies including assessment of safety signals as required
  • Develop and maintain strong working relationships with investigators and KOL’s and conduct thorough analyses of current standard of care in focused therapeutic areas to support advisory boards and development plans
  • Conduct literature searches, draft regulated clinical documents, publication abstracts, presentations and publications
  • Support the execution of clinical trials on time by working in a multi-disciplinary team setting with members from within company, CROs and consultants
  • This job role does not require individual to be medically qualified.

ROLE RESPONSIBILITIES

  • Scientific writing: Author or contribute to production of high-quality documents or sections thereof that are scientifically sound:
  • Clinical protocols and amendments
  • Clinical study reports
  • Investigator brochure
  • Documents to support health authority interactions including DSURs
  • Publications including abstracts and congress presentations
  • Translational medicine: Support development of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support development of stratification biomarkers.
  • Decision quality data generation:
    • Partner with data management and study medical monitor/ director for CRF design, instructions, data review plan and conduct frequent clinical data listing review
    • Partner with biostatistics and study medical monitor/director for statistical analysis plan review and finalization
  • In conjunction with study medical monitor create and/or review slides for internal and external meetings such as investigator meetings, SIVs, company-wide meetings
  • Participate in long-term clinical development and planning a pathway to regulatory registration for assigned therapeutic area(s)
  • Serve as clinical science representative on cross-function teams as assigned
  • Be able to multi-task, prioritize and be a self-starter

QUALIFICATIONS

  • This is an important, high profile role in a fast growing clinical development organization.
  • An advanced science degree (eg. PhD, PharmD)
  • 0-3 years of clinical trial experience in industry; experience working on cross-functional teams, closing a clinical study and authoring a clinical study report preferred
  • Highly motivated entry-level candidates will be considered with commensurate experience in working in industry in cross-functional teams, working on research protocols in industry setting and adhering to tight timelines; course-work covering fundamentals of GVP, ICH and familiarity with FDA guidelines preferred
  • Strong communication skills and ability to work effectively across multiple multidisciplinary teams.
  • Excellent oral and written communication skills.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Project Management, Director

ROLE SUMMARY

  • We are looking for an experienced Director for our Project Management Team. The successful candidate will be responsible for managing multiple highly complex development projects; co-lead early stage development team(s) to drive preclinical assets into the clinic. Work closely with the project team members representing preclinical, clinical, regulatory, and operations, CMC, quality, legal departments in a team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables. Provide regular project team deliverables and progress updates to Senior Management.

ROLE RESPONSIBILITIES

  • Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification of resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
  • Manage Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions (meeting minutes).
  • Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
  • Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment and manage timelines for regulatory submissions (IND/NDA/BLA/MAA, etc.).
  • Develop, track and maintain project publication plans, work with teams to identify key conferences and journals, coordinate publication development and publication gap analysis.
  • Assists in the review of project team regulatory documents and SOP revisions, if relevant.
  • Work closely Senior Management in ongoing enhancements and development of team processes, structures, and project reporting tools.

QUALIFICATIONS

  • BS in a scientific field required; Master’s degree preferred.
  • Strong understanding of Drug Development process and US and EU Regulatory requirements.
  • Minimum of 8+ years of project management experience in drug development
  • Exposure to early-stage programs (pre-clinical through Phase I/II proof-of-concept) essential; and exposure to late-stage programs (Phase II/III pivotal) a plus.
  • Able to work independently and creatively with minimal oversight
  • Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
  • Strong ability to proactively predict issues and solve problems, identify risks.
  • Strong ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
  • Proven ability to balance the strategic needs of the program with tactical day-to-day activities.
  • Excellent people (soft) skills, conflict resolution, diplomacy and positive influencing abilities.
  • Outstanding communication, planning and organizational skills.
  • Highly collaborative team player who fosters open communication and able to facilitate urgent needs.
  • Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project, Visio, PowerPoint and Excel, etc.).

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Safety MD, DVM, or RN

ROLE RESPONSIBILITIES

  • Organize, manage and actively carry out as appropriate, adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required, local contractual agreements, process documentation and training, inspection preparedness, and any other required safety activity
  • Carry out all case management activities as appropriate
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
  • Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
  • Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
  • Consistently apply regulatory requirements and TP Therapeutics policies
  • Analyze and monitor activities, define and implement corrective actions, where applicable
  • Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
  • Provide oversight and team mentoring on case handling aspects, data extraction and analyses
  • Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the organization
  • Act as subject matter expert for the DSUR
  • Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling

QUALIFICATIONS

  • Education: MD or DVM
  • Experience: Two to three years of clinical research and protocol management experience preferred.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com