Senior Director, Clinical Development (MD)

Company: G1 Therapeutics, Inc
Location: Raleigh
Posted on: February 22, 2021

Job Description:

Senior Director, Clinical Development (MD) G1 Therapeutics is a clinical-stage biopharmaceutical company focused on discovery, development, and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies. Trilaciclib --is a first-in-class investigational therapy designed to improve outcomes for people with cancer who are treated with chemotherapy.--A New Drug Application (NDA) for trilaciclib has been assigned Priority Review by the FDA, with an action date of February 15, 2021. G1 is also advancing--rintodestrant , a potential best-in-class oral selective estrogen receptor degrader, or SERD, for the treatment of ER+ breast cancer. In 2020, G1 out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor,--lerociclib . The Opportunity: G1 Therapeutics is currently recruiting a Senior Director, Clinical Development to join our team, reporting to the VP, Clinical Development. In the role of Senior Director, Clinical Development you will be responsible for providing medical leadership and input to G1's clinical development function and clinical trial activities. To be successful in this role, you must have significant experience in oncology drug development with a keen understanding of pharmaceutical processes and GxP requirements. NOTE: This position is currently remote based, with flexibility to remain so at a future date when we resume normal business practice at our HQ office in RTP, North Carolina. Responsibilities:

• Provide medical leadership for clinical trial activities, including:
  • Clinical trial development and successful execution of clinical development 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
  • Development of clinical protocols to support the company's product strategy, data collection and management and final reports developed in compliance with appropriate standard operating procedures, regulatory and medical standards
  • Contribute to other technical regulatory documents, eg., IBs, CSRs, DSUR, etc.
  • Provide oversight of CRO medical monitors, as needed
  • Direct the identification and use of clinical consultants as required
  • Provide leadership on cross-functional product development team, as needed
  • Responsible for KOL development, establishing relationships and communications with KOLs and investigators worldwide
  • Oversee planning and management of investigator meetings, advisory boards and other scientific committees, as needed
  • 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 business development and commercial efforts
  • Represent Clinical in communications with regulatory Agencies, Corporate executive management, Corporate partners and in public meetings
  • Provide clinical input to Business Development for partnering discussions and due diligence activities, as needed
  • Motivate and facilitate informed, timely, and impactful decision making across the organization
  • Develop and maintain a high performing operational approach including effective team building and conflict management; identify situations requiring escalation
  • Create a team environment that encourages cross-functional engagement, cooperation, accountability, and satisfaction
  • Other duties as assigned Requirements:
    • A minimum of 6 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
    • Scientific research and writing skills required; ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents
    • 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
    • Ability to handle complexity, prioritize and multi-task current project demands; must be able to prioritize and deliver effectively with minimal supervision
    • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
    • Ability to make sound and timely decisions, agile in learning and action oriented
    • High level of emotional intelligence; able to deal with ambiguity
    • Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skilled in negotiating organizational boundaries and hierarchy; able to build effective teams
    • Excellent written and verbal communication skills required
    • 15-20% travel Why Join Us? We know our employees are our most valuable asset, and our culture conveys that. All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff. An Equal Opportunity Employer G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics 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 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 protected by the laws or regulations in the locations where we operate. Do you now, or will you in the future, require sponsorship (e.g., H-1B visa status, etc.) to work legally for G1 Therapeutics in the United States?* Do you have recent experience (within past 3 years) working with oncology clinical trials?* Briefly describe your recent strategic development, including the design of clinical development plans, of oncology drugs (2-4 sentences).*

Keywords: G1 Therapeutics, Inc, Raleigh , Senior Director, Clinical Development (MD), Executive , Raleigh, North Carolina