VP Clinical Development, Oncology
Posted 13 days ago
Job Viewed
Job Description
**Job Overview**
We are seeking an experienced VP Clinical Development, Oncology to fulfill a critical and highly visible role to help shape the future of development at SMPA. This role is responsible for the successful strategic positioning and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs and Commercial functions. The VP Clinical Development, Oncology will be responsible for leading and designing clinical programs in Oncology at SMPA.
The ideal candidate will need deep expertise in Oncology with strong leadership skills, scientific rigor, and the ability to collaborate effectively with cross-functional teams. The VP Clinical Development, Oncology is expected to cultivate relationships with scientific leaders and serve as an outward-facing representative of the company to the scientific community. This role will report to the Chief Medical Officer- Oncology and will have functional responsibility for all clinical development activities in Oncology across all stages of development.
**Job Duties and Responsibilities**
Overview
+ Strategic Leadership: Lead the strategic and clinical direction of the cross-functional teams from preclinical experiments to the end of the product's life cycle.
+ Clinical Trial Oversight: Develop and oversee clinical trial strategies, ensuring alignment with corporate objectives and regulatory requirements for SMPA and the future oncology initiatives.
+ Medical Expertise: Deep knowledge and expertise in Oncology, scientific rigor and understanding of the different cross functional teams to interact for the best outcomes for SMPA.
+ Team Management: Lead and coordinate cross-functional teams to drive collaboration, enhance productivity and achieve goals effectively.
+ Regulatory Engagement: Interface with regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the regulatory landscape.
+ Data Analysis and Reporting: Oversee data interpretation, ensuring accurate and timely reporting to internal stakeholders, regulators, and the scientific community.
Strategic Leadership:
+ Provide medical vision and clinical leadership for the strategy and plan to advance SMPA's current and future product portfolio
+ Develop and execute the overall clinical development strategy for Oncology, aligning with SMPA's overall goals and regulatory requirements.
+ Lead the medical and scientific aspects of clinical trials, including protocol design, study endpoints, and data analysis.
+ Provide medical expertise to cross-functional teams, including regulatory, commercial, and clinical operations.
+ Provide day-to-day practical and overarching strategic guidance for Oncology clinical programs, ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information that allows for clear decision making and advancement of development efforts.
Clinical Trial Oversight:
+ Manage the full lifecycle of clinical trials, from feasibility assessment and site selection to data analysis and reporting.
+ Provide leadership to cross-functional teams to create scientifically rigorous and innovative trial protocols.
+ Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards.
+ Develop and execute corporate clinical strategy for global development projects in Oncology
+ Monitor clinical trial progress, identify and mitigate risks, and make necessary adjustments to study protocols.
Medical Expertise:
+ Provide medical vision and clinical leadership for the strategy and plan to advance SMPA's current and future product portfolio.
+ Collaborate with key opinion leaders and investigators to ensure optimal clinical trial design and execution.
+ Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing.
+ Stay abreast of emerging clinical trends and scientific advancements within Oncology.
+ Interpret clinical data, evaluate safety and efficacy, and make informed decisions regarding study continuation or termination.
+ Maintain understanding of competitors and clinical development in relevant areas of Oncology by attending scientific meetings and tracking literature.
Team Management:
+ Lead and mentor a team of clinical development professionals, including clinical project managers, medical monitors, and data analysts.
+ Oversee, plan, and manage the budget for Oncology clinical development activities.
+ Partner with Translational Research, Regulatory Affairs, Clinical Operations, and Medical Affairs to ensure the clinical program aligns with broader business goals.
+ Provide leadership and clinical expertise to the overall development organization including the clinical development, clinical operations, biometrics, clinical pharmacology, and non-clinical teams.
Regulatory Interactions:
+ Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions, clinical study reports, and NDA/MAA filings.
+ Collaborate with regulatory affairs team to ensure compliance with regulatory requirements.
**Key Core Competencies** :
+ A proven, impact-focused, builder and leader of high performing teams. Lead, mentor and manage a high-performing clinical development team, fostering collaboration and innovation
+ Ability to develop and successfully execute strategies at an organizational level.
+ Ability to collaborate effectively and build relationships with key stakeholders.
+ Capacity to make strategic decisions that have potential long-term positive impact.
+ Impeccable integrity, dependability, and a keen sense of urgency to achieve results.
+ Ability to adapt and quickly pivot according to business needs.
+ Ability to influence at all levels of the organization is a must.
+ Ability to manage, develop, and motivate a diverse team.
+ Ability to analyze complex clinical data and present findings clearly.
+ Significant experience with global clinical trials and regulatory process.
+ Credibility within the global medical and scientific community. Ability to forge solid personal and professional relationships with key opinion leaders is desired.
+ Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.
+ Strategic thinker with a hands-on approach.
+ Strong interpersonal and communication skills.
+ Excellent written and oral communication skills
**Education and Experience**
+ Medical Degree (MD) required
+ Additional training or certifications in clinical research, drug development, or Medical Oncology is highly desirable.
+ Minimum of 15 years of clinical development experience.
+ Experience with proven leadership in leading teams and progressing therapies in oncology through clinical development stages.
+ Experience leading programs through regulatory pathways, including IND and NDA filings and experience in interacting with regulatory agencies.
+ Experience in both large and small to mid-sized biotech companies preferred.
+ Experience presenting to a wide variety of audiences including internal teams, Executive Leadership, Board of Directors, medical and scientific communities.
The base salary range for this role is $ 329,600 to $412,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
#LI-MM1
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Field Medical Director-Radiation Oncology
Posted today
Job Viewed
Job Description
Your Future Evolves Here
Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and primary care, we seek to connect the pieces of fragmented health care system and ensure people get the same level of care and compassion we would want for our loved ones.
Evolent employees enjoy work/life balance, the flexibility to suit their work to their lives, and autonomy they need to get things done. We believe that people do their best work when they're supported to live their best lives, and when they feel welcome to bring their whole selves to work. That's one reason why diversity and inclusion are core to our business.
Join Evolent for the mission. Stay for the culture.
What You'll Be Doing:
As a FMD, you will be a key member of the utilization management team. We can offer you a meaningful way to make a difference in patients' lives, in a non-clinical environment. You can enjoy better work- life balance on a team that values collaboration and continuous learning while providing better health outcomes.
Collaboration Opportunities:
- Routinely interacts with leadership and management staff, other Physicians, and staff whenever a physician`s input is needed or required.
What You Will Be Doing:
-
Serve as the Physician match reviewer in Radiation Oncology and imaging cases, that do not initially meet the applicable medical necessity guidelines, as well as other imaging requests when providers, clients, or state laws require specialty reviews to be completed by the subject matter expert.
-
Discusses determinations (peer to peer phone calls) with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request and provides clinical rationale for standard and expedited appeals.
-
Utilizes medical/clinical review guidelines and parameters to assure consistency in the MD review process to reflect appropriate utilization and compliance with SBU`s policies/procedures, as well as Utilization Review Accreditation Commission (URAC) and National Committee for Quality Assurance (NCQA) guidelines.
-
Aids and acts as a resource to Initial Clinical Reviewers.
-
Ensures documentation of all communications with medical office staff and/or MD provider is recorded in a timely and accurate manner.
-
May assist the Senior Medical Director in research activities/questions related to the Utilization Management process, interpretation, guidelines and/or system support.
-
Participates in on-going training per inter-rater reliability process.
Qualifications-
-
MD/DO/MBBS
-
Minimum of five (5) years' experience in the practice of Medicine, post residency and Active Clinical practice within the last 2 years is preferred
-
Current, unrestricted clinical license in medicine or required specialty-
-
Obtaining and maintaining medical licenses in the state you reside, as well as, any license required per business needs
-
Active Board Certification in Radiation Oncology
-
Strong clinical, management, communication, and organizational skills
-
Energetic and curious with a passion for quality and value in health care
-
Computer Proficiency
To comply with HIPAA security standards (45 C.F.R. sec. 164.308 (a) (3)), identity verification may be required as part of the application process. This is collected for compliance and security purposes and only reviewed if an applicant advances to the final interview state. Reasonable accommodations are available upon request.
Technical Requirements:
We require that all employees have the following technical capability at their home: High speed internet over 10 Mbps and, specifically for all call center employees, the ability to plug in directly to the home internet router. These at-home technical requirements are subject to change with any scheduled re-opening of our office locations.
Evolent is an equal opportunity employer and considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. If you need reasonable accommodation to access the information provided on this website, please contact for further assistance.
The expected base salary/wage range for this position is $115-$130/hr. This position is also eligible for a bonus component that would be dependent on pre-defined performance factors. As part of our total compensation package, Evolent is proud to offer comprehensive benefits (including health insurance benefits) to qualifying employees. All compensation determinations are based on the skills and experience required for the position and commensurate with experience of selected individuals, which may vary above and below the stated amounts.
Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!
Field Medical Director-Radiation Oncology
Posted 13 days ago
Job Viewed
Job Description
Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and primary care, we seek to connect the pieces of fragmented health care system and ensure people get the same level of care and compassion we would want for our loved ones.
Evolent employees enjoy work/life balance, the flexibility to suit their work to their lives, and autonomy they need to get things done. We believe that people do their best work when they're supported to live their best lives, and when they feel welcome to bring their whole selves to work. That's one reason why diversity and inclusion are core to our business.
Join Evolent for the mission. Stay for the culture.
**What You'll Be Doing:**
As a FMD, you will be a key member of the utilization management team. We can offer you a meaningful way to make a difference in patients' lives, in a non-clinical environment. You can enjoy better work- life balance on a team that values collaboration and continuous learning while providing better health outcomes.
Collaboration Opportunities:
+ Routinely interacts with leadership and management staff, other Physicians, and staff whenever a physician`s input is needed or required.
What You Will Be Doing:
+ Serve as the Physician match reviewer in Radiation Oncology and imaging cases, that do not initially meet the applicable medical necessity guidelines, as well as other imaging requests when providers, clients, or state laws require specialty reviews to be completed by the subject matter expert.
+ Discusses determinations (peer to peer phone calls) with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request and provides clinical rationale for standard and expedited appeals.
+ Utilizes medical/clinical review guidelines and parameters to assure consistency in the MD review process to reflect appropriate utilization and compliance with SBU`s policies/procedures, as well as Utilization Review Accreditation Commission (URAC) and National Committee for Quality Assurance (NCQA) guidelines.
+ Aids and acts as a resource to Initial Clinical Reviewers.
+ Ensures documentation of all communications with medical office staff and/or MD provider is recorded in a timely and accurate manner.
+ May assist the Senior Medical Director in research activities/questions related to the Utilization Management process, interpretation, guidelines and/or system support.
+ Participates in on-going training per inter-rater reliability process.
Qualifications-
+ MD/DO/MBBS
+ Minimum of five (5) years' experience in the practice of Medicine, post residency and Active Clinical practice within the last 2 years is preferred
+ Current, unrestricted clinical license in medicine or required specialty-
+ Obtaining and maintaining medical licenses in the state you reside, as well as, any license required per business needs
+ Active Board Certification in Radiation Oncology
+ Strong clinical, management, communication, and organizational skills
+ Energetic and curious with a passion for quality and value in health care
+ Computer Proficiency
**To comply with HIPAA security standards (45 C.F.R. sec. 164.308 (a) (3)), identity verification may be required as part of the application process. This is collected for compliance and security purposes and only reviewed if an applicant advances to the final interview state. Reasonable accommodations are available upon request.**
**Technical Requirements:**
We require that all employees have the following technical capability at their home: High speed internet over 10 Mbps and, specifically for all call center employees, the ability to plug in directly to the home internet router. These at-home technical requirements are subject to change with any scheduled re-opening of our office locations.
**Evolent is an equal opportunity employer and considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.** **If you need reasonable accommodation to access the information provided on this website, please contact** ** ** **for further assistance.**
The expected base salary/wage range for this position is $115-$130/hr. This position is also eligible for a bonus component that would be dependent on pre-defined performance factors. As part of our total compensation package, Evolent is proud to offer comprehensive benefits (including health insurance benefits) to qualifying employees. All compensation determinations are based on the skills and experience required for the position and commensurate with experience of selected individuals, which may vary above and below the stated amounts.
Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!
Clinical Research Associate - Oncology
Posted 19 days ago
Job Viewed
Job Description
Key responsibilities include site selection and initiation, monitoring site activities, data verification, query resolution, and ensuring the quality and integrity of data collected. You will also be responsible for managing trial documentation, conducting site close-out visits, and serving as a liaison between the clinical trial staff, investigators, and the sponsor. This position requires a Bachelor's degree in a life science, nursing, or a related field; a Master's degree is a plus. A minimum of 3 years of experience as a CRA, with specific experience in oncology trials, is essential. Thorough knowledge of ICH-GCP guidelines and regulatory requirements is mandatory. Excellent communication, organizational, and interpersonal skills are critical. You must be detail-oriented, proactive, and possess strong problem-solving abilities. The ability to travel to clinical sites (up to 60%) is required. This is an excellent opportunity to join a leading pharmaceutical organization and contribute directly to the development of life-saving cancer therapies.
Office Specialist (Radiation Oncology, Casual)
Posted 5 days ago
Job Viewed
Job Description
**Job Description Summary:**
Provides Administrative Assistance to the operations of appropriate department. Responsible for patient registration, including data entry of patient information and insurance verification. Answers telephone and directs calls appropriately. Greets customers and patients.
**Responsibilities And Duties:**
Confirm patient demographic information
Verify insurance
Provide great Customer Service
Collect Co-pays
Education of Insurance and Billing
**Minimum Qualifications:**
High School or GED (Required)
**Additional Job Description:**
Demonstrated customer service and telephone skills. Knowledge in basic word processing and spreadsheet software. Knowledge of insurance, registration or billing processes and medical terminology. 1-2 years previous secretarial Experience in health care of medical office.
**Work Shift:**
Variable
**Scheduled Weekly Hours :**
1
**Department**
Radiation Oncology Offsite
Join us!
. if your passion is to work in a caring environment
. if you believe that learning is a life-long process
. if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion,
Senior Clinical Research Scientist - Oncology
Posted 13 days ago
Job Viewed
Job Description
Clinical Research Associate - Oncology Trials
Posted 13 days ago
Job Viewed
Job Description
Key duties include site initiation visits, routine monitoring visits, and close-out visits. You will review source documentation, case report forms (CRFs), and other essential trial documents to verify data accuracy and completeness. The CRA will also act as a liaison between the study sites, the clinical operations team, and the principal investigators, addressing any site-related issues promptly. Ensuring adherence to safety reporting procedures and managing investigational product accountability are also critical functions. The ideal candidate possesses strong knowledge of clinical trial processes, GCP, and regulatory guidelines. Excellent organizational, communication, and interpersonal skills are essential, along with the ability to travel to study sites as needed. Experience with oncology trials is a significant advantage. Join us in Columbus, Ohio and contribute to life-changing pharmaceutical research.
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About the latest Oncology Jobs in Columbus !
Laboratory Research Operations Consultant - Radiation Oncology
Posted 1 day ago
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Oncology
Posted today
Job Viewed
Job Description
Travel RN Oncology - GU/Uro Clinic - James Cancer Hospital - 8AM-4:30PM - No Call/No Weekends
Years of experience required: 5
First-timers accepted: YES
Weekend Requirement: None
Required Certifications: BLS
Total Travel Package
$2,050.00
Taxable Amount/week
$20.00
Non Taxable/week
1,330.00
Standard Taxable Rate
20.00
Overtime Rate
50.00
Hourly Per Diem
36.94
Maximum Lodging per week
910.00
Maximum M&IE per week
420.00
Per Diem/month
5,700.00
Assignment Gross
26,650.00
Job Requirements
Principal Clinical Research Associate - Oncology Trials
Posted 9 days ago
Job Viewed