Medical Director, Rare Autoimmune Nephrology
Posted on Oct 3, 2024 by Biogen
South San Francisco, CA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description
About This Role
HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead the MD and as a key member of the clinical development team, you will support the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
What You Will Do
Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent HI-Bio externally at scientific conferences, investor meetings, and other industry events
This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
About This Role
HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead the MD and as a key member of the clinical development team, you will support the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
What You Will Do
Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent HI-Bio externally at scientific conferences, investor meetings, and other industry events
This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
Reference: 203188123
https://jobs.careeraddict.com/post/95759828
Medical Director, Rare Autoimmune Nephrology
Posted on Oct 3, 2024 by Biogen
South San Francisco, CA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description
About This Role
HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead the MD and as a key member of the clinical development team, you will support the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
What You Will Do
Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent HI-Bio externally at scientific conferences, investor meetings, and other industry events
This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
About This Role
HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead the MD and as a key member of the clinical development team, you will support the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
What You Will Do
Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent HI-Bio externally at scientific conferences, investor meetings, and other industry events
This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
Reference: 203188123
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