Medical Development and Safety Officer - Astellas Pharma
Alameda, CA
About the Job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Alameda, California. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
About Us:
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.
iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.
Purpose and Scope:
As a critical member of the iota organization, the Medical Development and Safety Officer (MDSO) will support iota’s oncology program. The role leverages deep therapeutic area expertise and experience in the field of clinical oncology and helps the organization develop and sustain safe devices and services by offering a clear articulation of patient risk and safety in a comprehensive and dynamic manner throughout the device lifecycle. The MDSO augments medical judgment with both qualitative and quantitative application of scientific and medical analysis to promote patient safety, balance risk with benefit, guide strategy, and drive innovation.
This is a key medical role which provides leadership through influence across the organization and carries responsibility for ensuring that rigorous, proactive and reactive medical safety input is provided across all areas of the business.
Essential Job Responsibilities:
+ Provides medical expertise and assessment to support patient safety throughout the product lifecycle, including product development processes, risk management, clinical trials, post-market surveillance, and field actions.
+ Provides a clear and accountable point of escalation of observations of risk to patient safety to iota Biosciences senior leadership.
+ Exhibits the highest levels of ethics and accountability and acts as a key advocate for the patients and a function of medical safety to engage internal and external stakeholders in matters of medical device safety.
+ Provides specialized therapeutic area medical expertise throughout the device life cycle, including medical input into risk management, product complaints, vigilance reports, health risk assessments, field safety communications, and serves as a medical advisor for regulatory issues and in the creation of instructional material/labeling to ensure safe use of medical devices.
+ Provides direct medical input into clinical risk trending and safety signal detection, assessment, management and reporting. Liaises with clinical field personnel and HCPs when needed to assist in the assessment of significant adverse events. Advises on failure investigations and provides medical opinion in assessing health hazards posed by devices. Implements experience-based understanding of medical risk and benefit to arrive at objective assessments of health risk.
+ Undertakes periodic review of the state of the art in medical practice and the competitive landscape, with a focus on determining whether any adverse or mitigating safety signals can be assessed. This may include review of medical literature, clinical trial data, etc.
+ Provides independent review and approval (and occasionally authorship) of a range of clinical, scientific and safety documents and reports used for safety and performance assessment in various quality, risk management, clinical evidence processes, post-market surveillance and regulatory submission.
+ Contributes to internal development and assessment of novel technologies and provides medical safety evaluation in new business development activities.
+ Engages compliantly on behalf of iota Biosciences in external interactions with study investigators, regulatory bodies, KOLs, professional societies and advisory boards on matters of medical safety. Interacts with independent committees ensuring exchange of information with these committees is transparent and adequate to meet objectives of safety oversight.
+ Provides oversight and guidance to the development, training and mentorship of medical and non-medical personnel working on the device program who have safety-focused or adjacent roles.
Qualifications:
Required
+ MD/DO degree (or accepted international equivalent) required
+ Minimum of 3 years prior clinical practice in oncology (post degree)
+ In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, and other applicable requirements
+ Ability to influence decisions relating to patient safety and assessment of benefit-risk
+ Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus across the teams, and understand differences in both regulations and cultures.
+ Ability to convey complex medical concepts to a wide audience both internal and external to the company, across multiple levels of seniority, through formal and informal presentations and written reports.
+ Ability to deliver under pressure with limited resources.
+ Ability to travel to meet the needs of the role.
Preferred
+ 5 years of patient care experience beyond Residency/Fellowship
+ General understanding of clinical study design and clinical development for early-stage projects.
+ Past experience within a medical device or other life sciences company in one of the following functions: medical safety, medical affairs, clinical, R&D, quality, or regulatory.
+ Experience applying principles of risk management.
+ A general, working knowledge of applicable global medical device regulations, including FDA CFR 21, EU MDR, ISO 14971, ISO 14155, ISO 13485.
+ Experience interacting with FDA or other Regulatory Agencies.
+ Formal specialty training in surgical oncology.
+ If licensed to practice medicine, the candidate license would ideally be valid, unrestricted and unchallenged, and the candidate must be in good standing with the licensing body.
+ General, working knowledge of clinical statistical principles.
Benefits:
+ iota offers a very competitive benefits package that includes the following:
+ 100% employer paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, vision, and ADD. iota covers dependents at 100%.
+ Short-Term and Long-Term Disability
+ EAP
+ 401k plan – matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation.
+ Bonus Plan
+ Long Term Incentive Plan (LTIP)
+ 4 weeks of vacation, 2 floating holidays, and 9 Company paid holidays!
#LI-SS
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Alameda, California. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
About Us:
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.
iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.
Purpose and Scope:
As a critical member of the iota organization, the Medical Development and Safety Officer (MDSO) will support iota’s oncology program. The role leverages deep therapeutic area expertise and experience in the field of clinical oncology and helps the organization develop and sustain safe devices and services by offering a clear articulation of patient risk and safety in a comprehensive and dynamic manner throughout the device lifecycle. The MDSO augments medical judgment with both qualitative and quantitative application of scientific and medical analysis to promote patient safety, balance risk with benefit, guide strategy, and drive innovation.
This is a key medical role which provides leadership through influence across the organization and carries responsibility for ensuring that rigorous, proactive and reactive medical safety input is provided across all areas of the business.
Essential Job Responsibilities:
+ Provides medical expertise and assessment to support patient safety throughout the product lifecycle, including product development processes, risk management, clinical trials, post-market surveillance, and field actions.
+ Provides a clear and accountable point of escalation of observations of risk to patient safety to iota Biosciences senior leadership.
+ Exhibits the highest levels of ethics and accountability and acts as a key advocate for the patients and a function of medical safety to engage internal and external stakeholders in matters of medical device safety.
+ Provides specialized therapeutic area medical expertise throughout the device life cycle, including medical input into risk management, product complaints, vigilance reports, health risk assessments, field safety communications, and serves as a medical advisor for regulatory issues and in the creation of instructional material/labeling to ensure safe use of medical devices.
+ Provides direct medical input into clinical risk trending and safety signal detection, assessment, management and reporting. Liaises with clinical field personnel and HCPs when needed to assist in the assessment of significant adverse events. Advises on failure investigations and provides medical opinion in assessing health hazards posed by devices. Implements experience-based understanding of medical risk and benefit to arrive at objective assessments of health risk.
+ Undertakes periodic review of the state of the art in medical practice and the competitive landscape, with a focus on determining whether any adverse or mitigating safety signals can be assessed. This may include review of medical literature, clinical trial data, etc.
+ Provides independent review and approval (and occasionally authorship) of a range of clinical, scientific and safety documents and reports used for safety and performance assessment in various quality, risk management, clinical evidence processes, post-market surveillance and regulatory submission.
+ Contributes to internal development and assessment of novel technologies and provides medical safety evaluation in new business development activities.
+ Engages compliantly on behalf of iota Biosciences in external interactions with study investigators, regulatory bodies, KOLs, professional societies and advisory boards on matters of medical safety. Interacts with independent committees ensuring exchange of information with these committees is transparent and adequate to meet objectives of safety oversight.
+ Provides oversight and guidance to the development, training and mentorship of medical and non-medical personnel working on the device program who have safety-focused or adjacent roles.
Qualifications:
Required
+ MD/DO degree (or accepted international equivalent) required
+ Minimum of 3 years prior clinical practice in oncology (post degree)
+ In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, and other applicable requirements
+ Ability to influence decisions relating to patient safety and assessment of benefit-risk
+ Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus across the teams, and understand differences in both regulations and cultures.
+ Ability to convey complex medical concepts to a wide audience both internal and external to the company, across multiple levels of seniority, through formal and informal presentations and written reports.
+ Ability to deliver under pressure with limited resources.
+ Ability to travel to meet the needs of the role.
Preferred
+ 5 years of patient care experience beyond Residency/Fellowship
+ General understanding of clinical study design and clinical development for early-stage projects.
+ Past experience within a medical device or other life sciences company in one of the following functions: medical safety, medical affairs, clinical, R&D, quality, or regulatory.
+ Experience applying principles of risk management.
+ A general, working knowledge of applicable global medical device regulations, including FDA CFR 21, EU MDR, ISO 14971, ISO 14155, ISO 13485.
+ Experience interacting with FDA or other Regulatory Agencies.
+ Formal specialty training in surgical oncology.
+ If licensed to practice medicine, the candidate license would ideally be valid, unrestricted and unchallenged, and the candidate must be in good standing with the licensing body.
+ General, working knowledge of clinical statistical principles.
Benefits:
+ iota offers a very competitive benefits package that includes the following:
+ 100% employer paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, vision, and ADD. iota covers dependents at 100%.
+ Short-Term and Long-Term Disability
+ EAP
+ 401k plan – matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation.
+ Bonus Plan
+ Long Term Incentive Plan (LTIP)
+ 4 weeks of vacation, 2 floating holidays, and 9 Company paid holidays!
#LI-SS
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Source : Astellas Pharma