Medical Director Clinical Development Oncology/Hematology | | Research-Based Biopharmaceutical Compa
Medical Director Clinical Development Oncology/HematologyLocation:
San Francisco, CAContact:
email protected THE ROLE:
Medical Director Clinical Development Oncology/Hematology Research-Based Biopharmaceutical CompanyDESCRIPTION:
We are seeking an Executive Director, Clinical Development, with a track record of successfully developing Oncology therapiesOne must have the ability to thrive in a matrix environment and work collaboratively with internal stakeholders across different functionsOne should have practical experience in identifying, vetting, and managing external partnerships including vendors, academic and industry collaborators.This individual should have an expert-level of knowledge of drug development, as evidenced by a proven track record in setting short- and long-range drug development strategies and plans with previous filing experienceAdditionally, one must have a thorough understanding of pharmaceutical regulatory requirements and their impact on the development and execution of clinical trials.ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
The ideal candidate should be regarded as a thought leader in Oncology. One must have experience working in the biopharma industry. Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight. It is preferred this person have multiple years of line management experience.HIGHLIGHTS OF
Responsibilities:
One will be part of a team responsible for all scientific aspects of conceptualizing and planning trials. One will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans. Provides or oversees medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice. Coordinates the collection and analysis of clinical data for internal analysis and review. One will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings. Develops manuscripts for publication in peer-reviewed journals. One will be part of a team responsible for defending the clinical development program before regulatory authorities. Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff. Assists in the clinical evaluation of business development opportunities.DESIRED SKILLS AND
Qualifications:
MD or equivalent with 8
years' clinical, scientific, and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment. Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine. Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred. Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences, healthcare, consulting, or academia.CONTACT:
To learn more about this role, contact a member of our team at 267-483-5233 or email protected The Bandish Group, LLCLife Sciences Executive SearchGreater Philadelphia Regionwww.bandishgroup.com Recommended Skills Biology Biometrics Business Development Clinical Development Clinical Trials Clinical Works Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3n7fd6dy62rxfncpkg', 'ExternalApply-j3n7fd6dy62rxfncpkg'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n
n Estimated Salary: $20 to $28 per hour based on qualifications.
San Francisco, CAContact:
email protected THE ROLE:
Medical Director Clinical Development Oncology/Hematology Research-Based Biopharmaceutical CompanyDESCRIPTION:
We are seeking an Executive Director, Clinical Development, with a track record of successfully developing Oncology therapiesOne must have the ability to thrive in a matrix environment and work collaboratively with internal stakeholders across different functionsOne should have practical experience in identifying, vetting, and managing external partnerships including vendors, academic and industry collaborators.This individual should have an expert-level of knowledge of drug development, as evidenced by a proven track record in setting short- and long-range drug development strategies and plans with previous filing experienceAdditionally, one must have a thorough understanding of pharmaceutical regulatory requirements and their impact on the development and execution of clinical trials.ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
The ideal candidate should be regarded as a thought leader in Oncology. One must have experience working in the biopharma industry. Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight. It is preferred this person have multiple years of line management experience.HIGHLIGHTS OF
Responsibilities:
One will be part of a team responsible for all scientific aspects of conceptualizing and planning trials. One will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans. Provides or oversees medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice. Coordinates the collection and analysis of clinical data for internal analysis and review. One will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings. Develops manuscripts for publication in peer-reviewed journals. One will be part of a team responsible for defending the clinical development program before regulatory authorities. Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff. Assists in the clinical evaluation of business development opportunities.DESIRED SKILLS AND
Qualifications:
MD or equivalent with 8
years' clinical, scientific, and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment. Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine. Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred. Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences, healthcare, consulting, or academia.CONTACT:
To learn more about this role, contact a member of our team at 267-483-5233 or email protected The Bandish Group, LLCLife Sciences Executive SearchGreater Philadelphia Regionwww.bandishgroup.com Recommended Skills Biology Biometrics Business Development Clinical Development Clinical Trials Clinical Works Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3n7fd6dy62rxfncpkg', 'ExternalApply-j3n7fd6dy62rxfncpkg'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
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