Glaukos Corporation
Head of Pharmacology
Glaukos Corporation, Aliso Viejo, California, United States, 92656
How will you make an impact?
We are seeking an experienced, dynamic Head of Pharmacology to lead our pharmacology efforts in the development of ophthalmology pharmaceutical and combination products. This role involves strategic leadership, scientific oversight, and cross-functional collaboration to drive the successful development of innovative pharmaceutical drugs and drug-device combination products targeting ophthalmic diseases, including corneal, anterior, and posterior ocular segment diseases. The ideal candidate will have a strong background in ophthalmology, pharmacology, and combination product development, with a proven track record in bringing products from concept to market.
What will you do?
Strategic Leadership
Develop and implement pharmacology strategies for ophthalmic drugs including novel chemical entities, biologics, including gene and protein therapeutics and combination products, aligning with company goals and regulatory requirements.Provide scientific and technical leadership for preclinical and clinical pharmacology studies.Design nonclinical testing strategy based on relevant pharmacology models to identify lead drug candidates and formulations.Member of the Applied Research leadership team, including nonclinical and CMC members, setting strategic direction for scientific functions and developing the scientific organization.
R&D
Design, oversee, and interpret pharmacological studies to evaluate the safety pharmacology and efficacy of ophthalmic drugs and combination products in appropriate nonclinical models. Support compound and formulation selection by appropriate triage of studies.Collaborate with formulation scientists and device engineers to optimize drug delivery systems for ophthalmic applications such as eye drops, intraocular injections, and ocular implants with extended drug delivery.Conduct due diligence evaluations on potential in-license opportunities and advise senior management on acquisition of novel technologies to build the Glaukos portfolio.Manage external CROs conducting nonclinical pharmacology, screening, and efficacy studies.
Regulatory Compliance
Ensure all pharmacological activities comply with regulatory requirements from agencies such as the FDA, EMA, and other global health authorities.Prepare and review regulatory documentation, including Investigational New Drug (IND) application, New Drug Applications (NDAs), and Biological License Applications (BLAs).Serve as the pharmacology expert during regulatory inspections and interactions, as needed.
Data Analysis and Reporting
Analyze and interpret complex pharmacological data sets, integrating PK/PD data to support product development and regulatory submissions.Prepare scientific publications, white papers, and presentations for conferences and other scientific forums.
Team Development
Mentor and develop junior pharmacologists and scientists, fostering a collaborative and innovative research environment.Lead cross-functional project teams, including nonclinical research, development subteams and core project teams such as Nonclinical, CMC, regulatory, clinical, and commercial, to drive ophthalmic combination product projects forward.
How will you get there?
Minimum 15 years' experience in pharmacology within the pharmaceutical or biotechnology industries.Significant portion of experience focused on ophthalmology.Demonstrated industry experience in drug development from lead identification through clinical trials.Proven track record in the development of ophthalmic drugs and combination products, from concept through to regulatory approval.Extensive experience with regulatory submissions and interactions, particularly with ophthalmic products.Strong understanding of pharmacology, nonclinical models related to ophthalmology diseases, pharmacodynamics, and drug delivery systems specific to ophthalmology.Excellent leadership, communication, and project management skills.Ability to analyze and interpret complex data sets and translate findings into actionable insights.Proficiency in preparing and reviewing scientific and regulatory documents.Able to see the big picture, aligning pharmacology strategies with overall company goals.Deep knowledge of pharmacological principles, methodologies, and challenges specific to ophthalmic products.Understanding of the regulatory landscape for ophthalmic products and ability to navigate it effectively.Ability to work effectively across different functions and with external partners to drive project success.
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We are seeking an experienced, dynamic Head of Pharmacology to lead our pharmacology efforts in the development of ophthalmology pharmaceutical and combination products. This role involves strategic leadership, scientific oversight, and cross-functional collaboration to drive the successful development of innovative pharmaceutical drugs and drug-device combination products targeting ophthalmic diseases, including corneal, anterior, and posterior ocular segment diseases. The ideal candidate will have a strong background in ophthalmology, pharmacology, and combination product development, with a proven track record in bringing products from concept to market.
What will you do?
Strategic Leadership
Develop and implement pharmacology strategies for ophthalmic drugs including novel chemical entities, biologics, including gene and protein therapeutics and combination products, aligning with company goals and regulatory requirements.Provide scientific and technical leadership for preclinical and clinical pharmacology studies.Design nonclinical testing strategy based on relevant pharmacology models to identify lead drug candidates and formulations.Member of the Applied Research leadership team, including nonclinical and CMC members, setting strategic direction for scientific functions and developing the scientific organization.
R&D
Design, oversee, and interpret pharmacological studies to evaluate the safety pharmacology and efficacy of ophthalmic drugs and combination products in appropriate nonclinical models. Support compound and formulation selection by appropriate triage of studies.Collaborate with formulation scientists and device engineers to optimize drug delivery systems for ophthalmic applications such as eye drops, intraocular injections, and ocular implants with extended drug delivery.Conduct due diligence evaluations on potential in-license opportunities and advise senior management on acquisition of novel technologies to build the Glaukos portfolio.Manage external CROs conducting nonclinical pharmacology, screening, and efficacy studies.
Regulatory Compliance
Ensure all pharmacological activities comply with regulatory requirements from agencies such as the FDA, EMA, and other global health authorities.Prepare and review regulatory documentation, including Investigational New Drug (IND) application, New Drug Applications (NDAs), and Biological License Applications (BLAs).Serve as the pharmacology expert during regulatory inspections and interactions, as needed.
Data Analysis and Reporting
Analyze and interpret complex pharmacological data sets, integrating PK/PD data to support product development and regulatory submissions.Prepare scientific publications, white papers, and presentations for conferences and other scientific forums.
Team Development
Mentor and develop junior pharmacologists and scientists, fostering a collaborative and innovative research environment.Lead cross-functional project teams, including nonclinical research, development subteams and core project teams such as Nonclinical, CMC, regulatory, clinical, and commercial, to drive ophthalmic combination product projects forward.
How will you get there?
Minimum 15 years' experience in pharmacology within the pharmaceutical or biotechnology industries.Significant portion of experience focused on ophthalmology.Demonstrated industry experience in drug development from lead identification through clinical trials.Proven track record in the development of ophthalmic drugs and combination products, from concept through to regulatory approval.Extensive experience with regulatory submissions and interactions, particularly with ophthalmic products.Strong understanding of pharmacology, nonclinical models related to ophthalmology diseases, pharmacodynamics, and drug delivery systems specific to ophthalmology.Excellent leadership, communication, and project management skills.Ability to analyze and interpret complex data sets and translate findings into actionable insights.Proficiency in preparing and reviewing scientific and regulatory documents.Able to see the big picture, aligning pharmacology strategies with overall company goals.Deep knowledge of pharmacological principles, methodologies, and challenges specific to ophthalmic products.Understanding of the regulatory landscape for ophthalmic products and ability to navigate it effectively.Ability to work effectively across different functions and with external partners to drive project success.
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