G1 Therapeutics, Inc. Sr. Director, Clinical Scientist in Research Triangle Park, North Carolina
G1 Therapeutics is committed to our mission of improving the lives of people impacted by cancer by developing and commercializing innovative therapies for a variety of tumor types. We know how a cancer diagnosis affects a person and their family, and we are driven every day to do everything we can to improve outcomes in people who have received the diagnosis. In addition to driving adoption of our first FDA-approved breakthrough drug for appropriate patients with extensive-stage small cell lung cancer, we are also developing a robust, late-stage clinical pipeline assessing the potential for our medicine in a variety of additional cancers. Our strategy leverages the experience and drive of the G1 team and our deep experience in inventive and responsible drug development and commercialization. G1 provides a professional, diverse, inclusive, and creative working environment where individuals can thrive. We offer an opportunity to bring your best to the team every day, and in doing so, help to save and improve the lives of people living with cancer and their families. We are driven to succeed by the patient communities we seek to help. Patients are waiting.
G1 Therapeutics is currently recruiting a Sr. Director, Clinical Scientist to join our team in Research Triangle Park, NC. The senior director level clinical scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams to ensure the timely execution of the clinical development plan. Requires minimal supervision from the medical director in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data. Closely collaborates with Clinical Operations in the overall conduct and timely execution of clinical trials. Works in collaboration with other key stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.
Author key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, investigator’s brochures, annual reports and clinical sections of regulatory submissions
In conjunction with clinical operations team, participate in selection of investigators, clinical sites, and vendors (including CRO)
Accountable for the clinical/scientific execution of the clinical protocol.
Accountable for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders (e.g., investigator meeting presentations, data review and summary, protocol deviation review, etc.)
Create and maintain clinical development plans to be aligned with Target Product Profile
Develop and perform clinical data review plans for clinical studies
Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.
Builds relationships with external scientific and clinical thought leaders
Author abstracts and prepare posters for external presentation
Establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems (eCRF), and final reports
Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.
Able to work independently as well as contribute as part of an interdisciplinary team
Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes
Leads mentorship of newly hired clinical scientists
BSN, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred with strong scientific knowledge and skillset
A minimum of 14+ years’ experience in the pharmaceutical industry, with minimum 5-8 years clinical development/clinical operations experience in oncology
Requires thorough understanding of the drug development process from pre-IND through registration and post-registration
Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management
Candidates must possess highly effective communication skills and be fluent in the English language, both written and verbal.
Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust overall clinical development strategy
Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader
Ability to work independently and to organize priorities and deliverables
The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
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.
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