Sr. Medical Director, Clinical Development

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.


Hybrid


Employee Value Proposition:


At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to lead global clinical trials and experience multiple facets of Clinical Development in a dynamic, supportive, collaborative, and global cross-functional environment.


Position Summary:


This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.


Performance Objectives:

• Assume the medical leadership on global clinical trials for Taiho Oncology, Inc. (TOI).
• Serve as a responsible clinical development lead and medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed.
• Use medical/scientific expertise and strategic thinking to develop clinical development plans and study designs (incl. use of companion diagnostics).
• Create or support the creation of relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents, and scientific publications.
• Answer medical questions raised by Competent Authorities (CA) and Institutional Review Boards/ Ethics Committees (IRBs/ECs) relevant to the studies.
• Review and sign off on clinical documents related to clinical studies as outlined by the manager.
• Attend study site initiation visits (SIV) and provides therapeutic area, compound, and protocol-specific trainings.
• Review, discuss, and answer any questions from the study sites regarding a patient's eligibility, dose adjustments, and patient's discontinuation.
• Perform data review supported by the CRS on an ongoing basis. Review of the safety data will be done through data listings and the electronic data capture (EDC) platform.
• Review and participate in the protocol deviation meeting that will occur monthly or as needed.
• Build and maintain effective relationships with clinical key opinion leaders in various different areas of disease in which Taiho is developing drugs.
• Collaborate with all department heads within TOI (Head of Clinical Research and Head of Clinical Operations) to establish operational plans and timelines for respective studies within each of the development programs
• Keeps management current on status of both clinical trials and provides ongoing risk assessments for the study conduct and operational risks. Represent the molecule at senior management governance meetings.
• Co-responsible with Clinical Development, Project Management, and Head of Clinical Operations for delivering the conduct and reporting of both trials within agreed timelines.
• Responsible for the medical oversight of a Clinical Research Scientist (CRS) who will participate in the medical review process and other study related activities in support of the Medical Monitor.
• Collaborate with Clinical Operations/trial management in vendor oversight.
• Continually assesses if adequate resources are available to meet clinical trial deliverables and milestones.
• Perform other duties as required.

Education/Certification Requirements:

• Successful completion of MD training mandatory; ≥3 years of clinical experience in treating oncology patients or a completed fellowship in a Hematology-Oncology program.
• Hematology or Oncology Board eligibility or certification preferred.
• Clinical practice experience of a minimum of 3-5 years preferred.

Knowledge, Skills, and Abilities:

• 7-10 years combined experience in academic and/or industry oncology clinical research and drug development, including experience as medical monitor and (sub)investigator on a clinical oncology trial.
• At least 2 years in drug development industry in oncology and with previous exposure to clinical development and regulatory documents such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, IB, ICF, CSR.
• Working knowledge of the drug development process in the USA and EU is required.
• Experience in direct interactions with US and/or EU Regulatory authorities is preferred.
• Highly detail and quality oriented.
• Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
• Ability to understand and implement prioritization of deliverables as well as recognize and highlight conflicts in priorities.
• Excellent presentation skills.
• Track record of scientific publications in peer reviewed journals is highly preferred.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $318,750 - $375,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.


If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.


#Location-Princeton,NJ #LI-Hybrid Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email [email protected] . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.