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Vice President, Clinical Development

G1 Therapeutics, Inc

This is a Full-time position in Remote, TX posted August 24, 2021.

G1 Therapeutics is currently recruiting a Vice President, Clinical Development to join our team.

Reporting to the Chief Medical Officer this position will eventually be based in our corporate office in Research Triangle Park, NC.

In the role of Vice President, Clinical Development you will provide medical leadership and input to G1’s clinical development function and clinical trial activities, as well as fostering the growth and development for the clinical development teams.

Responsibilities: Program lead including responsibility for clinical development plan and activities relevant to the successful implementation of the plan: Clinical trial development and execution of plans Assessment of safety parameters of enrolled subjects, including serious adverse events and relevant adverse events Advise on study-related medical questions and problems Analysis, interpretation and reporting of clinical study results to prepare documentation required for regulatory submissions and approvals Ensure ethical conduct of clinical programs Collaborate with internal stakeholders such as translational medicine and biomarkers, biometrics, and clinical operations to ensure robust protocol development to meet corporate objectives Development of clinical protocols to support the company’s product strategy, data collection and management and final clinical study reports developed in compliance with appropriate standard operating procedures, regulatory and medical standards Direct the identification and use of clinical consultants as required Responsible for KOL development, establishing relationships and communications with KOLs and investigators worldwide Monitor changes in the regulatory/medical environment which may impact the global drug development process Manage the development, finalization and submission of abstracts, scientific presentations and publications Provide clinical expertise and input to commercial efforts Represent Clinical in communications with regulatory Agencies, Corporate executive management, Corporate partners and in public meetings Provide clinical input to Corporate Development and for partnering discussions and due diligence activities as needed Ensure budgets and timelines meet corporate requirements Maintain the highest level of scientific, clinical and ethical knowledge in drug development Hire and supervise employees; foster the growth and development and provide mentorship for the clinical development team Oversee performance management and career development for direct reports Requirements: MD/DO or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty A minimum of 15 years of experience in drug development; preferably in industry Excellent understanding of pharmaceutical processes and GxP requirements Ability to understand and interpret the regulatory requirements under which drugs are developed, reviewed, and supported after approval.

Track record of excellence in the strategic development of oncology drugs, including the design and management of clinical development plans for new molecular entities and new indications for established products, reflecting a commitment to goals and delivery of results within planned timeframes and budgets Established relationships/connections with Key Opinion Leaders Excellent leadership skills and proven ability to effectively work in a cross-functional environment Significant experience/interactions with regulatory authorities in US and EU Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways Strong interpersonal, influencing, presentation, and written and verbal communication skills Strong organizational and time management skills Robust leadership skills with ability to lead/manage the work of others by providing guidance to team based on organizational goals and company policy, with responsibility for delivering results according to timelines and within the budget Up to 30% travel

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