Senior Director, Global Clinical Development CNS
Posted 7 days ago
Job Viewed
Job Description
Position Summary
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
Key Job Responsibilities
-
Conceives, implements, and analyzes drug development programs, including:
-
Understanding pharmacology of drugs and unmet medical needs.
-
Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
-
Working with experts and consultants in the field to refine a clinical development strategy.
-
Designing clinical trials for the purpose of meeting specific objectives.
-
Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
-
Implements clinical development programs, including:
-
Co-authoring global clinical development plans with all practical elements.
-
Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
-
Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
-
Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
-
Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
-
Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
-
Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
-
Partners with internal decision makers to evaluate critical decision points.
-
Acts as a signatory for the medical monitoring team.
-
Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
-
Participates in NDA development, submission and defense.
-
Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
-
Mentors junior team members.
Knowledge, Skills, Competencies, Education, and Experience
Required:
-
A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
-
Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
-
An advanced understanding of clinical medicine and science.
-
Advanced understanding of drug development principles and clinical trial implementation and management.
-
Complete understanding of the global regulatory requirements.
-
Working knowledge of marketing and commercialization.
-
Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
-
Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
-
Demonstrated experience in leading a successful regulatory filing.
-
Ability to work across different therapeutic areas and different stages of clinical development.
-
Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
-
Strong communication and presentation skills.
-
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
-
Knows how/when to apply organizational policy or procedures to a variety of situations.
Physical Demands and Work Environment
Travel (approximately 30 % )
See document Physical Demands and Work Environment for further requirements.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development CNS
Posted 18 days ago
Job Viewed
Job Description
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
**Key Job Responsibilities**
+ Conceives, implements, and analyzes drug development programs, including:
+ Understanding pharmacology of drugs and unmet medical needs.
+ Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
+ Working with experts and consultants in the field to refine a clinical development strategy.
+ Designing clinical trials for the purpose of meeting specific objectives.
+ Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
+ Implements clinical development programs, including:
+ Co-authoring global clinical development plans with all practical elements.
+ Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
+ Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
+ Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
+ Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
+ Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
+ Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
+ Partners with internal decision makers to evaluate critical decision points.
+ Acts as a signatory for the medical monitoring team.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
+ Participates in NDA development, submission and defense.
+ Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
+ Mentors junior team members.
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in leading a successful regulatory filing.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
**Physical Demands and Work Environment**
Travel (approximately 30 **%** )
See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
RN Clinical Research
Posted 13 days ago
Job Viewed
Job Description
**Job Summary**
Responsible for participating, conducting, and managing clinical research studies. Acts as a liaison between the clinic and the outside sponsoring firm. Coordinates and manages patient participation and data management for assigned studies.
**Essential Functions**
+ Recruit patient population and assists the physician(s) to identify patients and determine eligibility.
+ Conducts Informed Consent sessions with interested research subjects in compliance with all applicable federal, state and local regulations as well as the standards of Good Clinical Practice and the policies and procedures mandated by the study sponsor.
+ Responsible for establishing and maintaining a record-keeping system for each study. Maintain permanent records on all research protocols and cooperate with the study sponsor. Collect data through all phases of the study & assures appropriate completion of all documentation.
+ Provide and communicate protocol information and support to patients, physicians, research staff and all associated sponsor personnel or ancillary study personnel participating in active protocols.
+ Communicates appropriately with the person served regardless of their age.
+ Performs other duties as assigned.
**Qualifications**
**Education**
+ Associate Degree Required: Nursing and
+ Bachelor's Degree Preferred: Nursing.
**Experience**
+ Minimum of 3 years Required: Nursing experience in field relevant to hiring department and
+ Preferred: Clinical research experience
**Credentials**
+ Required: Registered Nurse in state of practice and
+ Preferred: Oncology Certified Nurse and
+ Preferred: Association of Clinical Research Certified Professional and
+ May be required Upon Hire: Basic Life Support and
+ May be required: National Institute of Health Stroke Scale Certification
**Skills**
+ Excellent organizational skills (Required)
+ Strong communication skills, both verbal and written (Required)
+ Problem solving skills (Required)
+ The ability to work independently in a multi-task environment (Required)
+ Proficient computer skills including Microsoft Office applications (Required)
+ Self-starter (Required)
+ Familiarity with health record data base systems (Preferred)
**Working Conditions**
Lifting
+ Consistently operates computer and other office equipment.
+ Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
+ Sedentary work.
Environmental Conditions
+ Predominantly operates in an office environment.
+ Some time spent on site in medical/hospital setting.
Mental/Visual
+ Ability to communicate and exchange accurate information.
+ The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
PeaceHealth is seeking a RN Clinical Research for a Full Time, 1.00 FTE, Day position. The salary range for this job opening at PeaceHealth is $49.64 - $74.46. The hiring rate is dependent upon several factors, including but not limited to education, training, work experience, terms of any applicable collective bargaining agreement, seniority, etc.
PeaceHealth is committed to the overall wellbeing of our caregivers: physical, emotional, financial, social, and spiritual. We offer caregivers a competitive and comprehensive total rewards package. Some of the many benefits included in this package are full medical/dental/vision coverage; 403b retirement plan employer base and matching contributions; paid time off; employer-paid life and disability insurance with additional buyup coverage options; tuition and continuing education reimbursement; wellness benefits, and expanded EAP and mental health program.
See how PeaceHealth is committed to Inclusivity, Respect for Diversity and Cultural Humility ( .
For full consideration of your skills and abilities, please attach a current resume with your application. EEO Affirmative Action Employer/Vets/Disabled in accordance with applicable local, state or federal laws.
REQNUMBER: 114849
Clinical Research Coordinator 1 - Oncology
Posted 2 days ago
Job Viewed
Job Description
At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mission - partnering and healing for a healthy future - and dedicated to the health and well-being of the communities we serve.
FTE: 1.0, Shift: Day, Schedule: Monday - Friday, potential for weekend work
Position SummaryThe Clinical Research Coordinator I is responsible for the implementation of clinical studies, typically basic science, phase II, III, and IV trials, and IIR studies. This position requires interaction with a wide variety of internal and external groups to include nursing staff, management, physicians, patients, outside organizations, research groups and service groups such as laboratories, pharmacy and radiology.
Responsibilities- Coordinates clinical research pertaining to clinical research in human subjects.
- Follows guidelines for identifying subject populations, complete forms, questionnaires, and clinic procedures for collecting and summarizing observations and data.
- Prepares for and participates in study monitor visits.
- May perform venous blood draws within the practice scope of a Medical Assistant Phlebotomy license.
- Coordinates and oversees processing, inventory and shipping of study specimens.
- Documents and maintains accurate records of study visits and procedures to include financial accrual, source document and eCRF completion in compliance with applicable regulations and department procedures.
- Completes and submits sponsor queries within 3 5 business days from receipt.
- High school education required
- Bachelors' degree in science, healthcare or other related fields preferred
- Minimum 1-year prior experience as a research assistant or coordinator within a healthcare setting
- CPR required
- Valid Washington State driver's license
As a MultiCare employee, we'll rely on you to reflect our core values of Respect, Integrity, Stewardship, Excellence, Collaboration and Kindness. Our values serve as our guiding principles and impact every aspect of our organization, including how we provide patient care and what we expect from each other.
Why MultiCare?- Belonging: We work to create a true sense of belonging for all our employees
- Mission-driven: We are dedicated to our mission of partnering for healing and a healthy future and the patients and communities we serve
- Market leadership: Washington state's largest community-based, locally governed health system
- Employee-centric: Named Forbes "America's Best Employers by State" for several years running
- Technology: "Most Wired" health care system 15 years in a row
- Leading research: MultiCare Institute for Research & Innovation, 40 years of ground-breaking, clinical and health services research in our communities
- Lifestyle: Live and work in the Pacific Northwest - offering breathtaking water, mountains and forest at every turn
We provide a comprehensive benefits package, including competitive salary, medical, dental and retirement benefits and paid time off. As required by various pay transparency laws, we share a competitive range of compensation for candidates hired into each position. The pay scale is $28.13 - $40.49 USD. However, pay is influenced by factors specific to applicants, including but not limited to: skill set, level of experience, and certification(s) and/or education. If this position is associated with a union contract, pay will be reflective of the appropriate step on the pay scale to which the applicant's years of experience align.
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