Clinical Sciences (Assoc Dir, Dir, Sr. Dir)

Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
SUMMARY
Working closely with the Clinical Operations Team, responsible for supporting and executing on clinical trial conduct. Serves as the lead Clinical Research Scientist on one or more specific studies or programs within the portfolio and may serve as Clinical Lead on cross-functional program level teams. Applies medical/scientific, operational, and drug development expertise to process development and standardization across the Zentalis' clinical programs as well as to support the functional supervision and training of clinical research scientists assigned to specific programs within the portfolio. Provides strategic clinical science support for Zentalis programs in clinical development
RESPONSIBILITIES

• Support of the design and execution of assigned clinical trial and/or program and work closely with clinical operations team and additional cross functional study team members within the assigned project to execute activities associated with the conduct of the clinical trials. May be assigned to one or one or more trials or programs based on experience.
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
• In collaboration with Data Management will assist with the development of a Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Assists in providing input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians.
• In concert with Clinical Sciences Physicians, provides clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts).
• Works independently and exercises judgment in resolving critical problems not always covered by existing standards, policies and procedures.
• Participates in the ongoing development and/or enhancement clinical development processes, structures, systems, tools, and other resources.
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Provides a high level of scientific leadership and interact with other Company leaders to ensure corporate success.
• Communicate data clearly and drive discussions to effective and actionable conclusions.
• Other projects as deemed appropriate.

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
• 8-10 years pharma/biotech industry experience; or relevant equivalent clinical; or relevant laboratory research experience with a minimum of 6 years' experience with clinical trials
• Minimum 6 years of relevant oncology therapeutic area experience
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall global drug development process
• Proven ability to work within a matrix management structure to influence programs
• Demonstrated ability to lead through others and develop emerging leaders within organization
• Ability to work productively and collaboratively with potential corporate partners/external collaborators
• Ability to multi-task/ prioritize and time management of daily activities
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
• High attention to detail
• Demonstrates high level of accuracy and effective oral and written communication skills
• Flexibility within a rapidly changing environment
• Excellent ability to work in a goal and team-oriented setting
• Well-developed organizational skills and the ability to thrive under pressure