Sobi
Medical Director, Clinical Science
Sobi, Waltham, Massachusetts, United States, 02254
Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:Competitive compensation for your workGenerous time off policySummer FridaysOpportunity to broaden your horizons by attending popular conferencesEmphasis on work/life balanceCollaborative and team-oriented environmentMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description
The Medical Director, Clinical Science is responsible for Sobi's clinical development activities on a product/indication and serves as scientific and medical expert on matters relating to the assigned development program including operational, regulatory and drug safety. Previous experience working on and monitoring clinical trials is required, experience working on regulatory submission documents preferred, and prior experience in Immunology is a plus.
Remote - US Eastern Time Zone, Boston area or Raleigh-Durham area preferred
Key Responsibilities
Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success.Act as Medical Director responsible for Sobi-sponsored studies.Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other core members of the development team, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.Member of the Medical Development Team and of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy.Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.Responsible to development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriateProvide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate.Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority's questions to support e.g., briefing documents, scientific advice, BLA/MAA applications.Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.To be successful in these activities, the Medical Director, Clinical Science will possess and continue to develop significant level of knowledge in assigned therapeutic area. Will develop productive relationships and contributions within the cross-functional headquarter team, as well as with local affiliate offices, and collaborative partners. Will role model the highest scientific and ethical standards, and work in accordance with applicable rules and regulations with regards to scientific and medical activities.Qualifications
Medical Degree required.At least 4 years clinical experience treating patients and/or at least 10 years of solid record of accomplishment within drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trialsTherapeutic and/or clinical trial experience with sirolimus and uricase enzymes preferredExpertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision makingGood communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposiaGood organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operationsGood team-player with high personal and scientific integrityComfortable working in fast paced environmentAble to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.Demonstrated lateral leadership in a fast paced, agile highly competitive therapeutic environment, with strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict resolution skills.Ability to work effectively in a matrix, cross-functional setting; excellent collaboration skills; and experience working with co-development/co-commercialization industry partners would be beneficialAble to work well in a virtual environment. Proven self-management by showing initiative, good organization and willingness to be held accountable.Ability to work independently with high level of self-motivation at the same time be a team player and have cross-cultural literacy.
The base salary pay range for this role is $190,000-270,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.
Additional Information
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
Why Join Us?
We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can't change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. 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 use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com
COVID-19 Policy
For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.
Videos To Watchhttps://www.youtube.com/watch?v=BZtAI7qxiHs
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:Competitive compensation for your workGenerous time off policySummer FridaysOpportunity to broaden your horizons by attending popular conferencesEmphasis on work/life balanceCollaborative and team-oriented environmentMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description
The Medical Director, Clinical Science is responsible for Sobi's clinical development activities on a product/indication and serves as scientific and medical expert on matters relating to the assigned development program including operational, regulatory and drug safety. Previous experience working on and monitoring clinical trials is required, experience working on regulatory submission documents preferred, and prior experience in Immunology is a plus.
Remote - US Eastern Time Zone, Boston area or Raleigh-Durham area preferred
Key Responsibilities
Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success.Act as Medical Director responsible for Sobi-sponsored studies.Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other core members of the development team, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.Member of the Medical Development Team and of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy.Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.Responsible to development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriateProvide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate.Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority's questions to support e.g., briefing documents, scientific advice, BLA/MAA applications.Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.To be successful in these activities, the Medical Director, Clinical Science will possess and continue to develop significant level of knowledge in assigned therapeutic area. Will develop productive relationships and contributions within the cross-functional headquarter team, as well as with local affiliate offices, and collaborative partners. Will role model the highest scientific and ethical standards, and work in accordance with applicable rules and regulations with regards to scientific and medical activities.Qualifications
Medical Degree required.At least 4 years clinical experience treating patients and/or at least 10 years of solid record of accomplishment within drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trialsTherapeutic and/or clinical trial experience with sirolimus and uricase enzymes preferredExpertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision makingGood communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposiaGood organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operationsGood team-player with high personal and scientific integrityComfortable working in fast paced environmentAble to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.Demonstrated lateral leadership in a fast paced, agile highly competitive therapeutic environment, with strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict resolution skills.Ability to work effectively in a matrix, cross-functional setting; excellent collaboration skills; and experience working with co-development/co-commercialization industry partners would be beneficialAble to work well in a virtual environment. Proven self-management by showing initiative, good organization and willingness to be held accountable.Ability to work independently with high level of self-motivation at the same time be a team player and have cross-cultural literacy.
The base salary pay range for this role is $190,000-270,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.
Additional Information
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
Why Join Us?
We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can't change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. 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 use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com
COVID-19 Policy
For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.
Videos To Watchhttps://www.youtube.com/watch?v=BZtAI7qxiHs