Successful Clinical stage biopharmaceutical company with the scientific vision of revolutionizing the cancer treatment in various indications. Company has extensive drug discovery and clinical development programs and building a portfolio of products addressing a wide range of therapies for a multiple combination of regimens.
Director Clinical Scientist will be a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position works independently across functional teams to ensure the timely execution of the clinical development plan. Requires minimal supervision 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 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 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 (e.g., investigator meeting presentations, safety and medical monitoring)
- 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.
- Works collaboratively with external project leaders to initiate clinical studies based on sound scientific rationale and clearly defined endpoints.
- 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.
- BS, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred.
- A minimum of 7+ years’ experience in the pharmaceutical industry, with minimum 3 – 6 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, 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, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
up to low $200's + Annual Bonus + Equity stock options
North Carolina area
TG - 701