Director/Sr. Director, Clinical Scientist

Circle Pharma is a dynamic biotech company that has raised $160 million to date from industry-leading investors. We are transitioning into a clinical-stage company, and we're currently developing a first-in-class precision oncology pipeline that addresses severe unmet medical needs by harnessing a novel, cell-permeable, oral macrocycle platform.

We seek candidates who desire to make key contributions to help drive our growth. For more information about Circle Pharma, please see our website,  www.circlepharma.com.

Circle Pharma is seeking an experienced drug development professional to join the early development team as the company moves its first asset into clinical trials. Reporting to the SVP, and Head of Early Development, the Director/Senior Director, Clinical Scientist will oversee one or more clinical development programs. This individual is responsible for the planning and execution of clinical studies to move programs from IND/CTA through to later stage trials. 

The Director/Senior Director Clinical Scientist is a pivotal role responsible for guiding the clinical science aspects of protocol development, study planning, data generation, and reporting for assigned projects. This individual will work closely with cross-functional teams, including medical, regulatory, clinical operations, clinical pharmacology, biostatistics, and data management to develop innovative and efficient solutions to medical and scientific clinical trial issues, and ensure the successful design, analysis, and completion of clinical trials. In addition, this individual will play a leadership role in the Clinical Development team and mentor or manage others in the Clinical Science function.

What You'll Do:

• Design, oversee, and execute clinical deliverables in support of CDP including document development (INDs, Protocols, IBs, applicable regulatory documents, etc.) medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), and data review process, and other deliverables as needed.
• Lead and collaborate on the design, conduct, reporting, and analysis of clinical studies.
• Serve as one of the primary contacts for site-facing activities such as training and support for clinical questions.
• Conduct and oversee activities related to data generation and validation, including CRF design, and clinical data review/query resolution; patient eligibility reviews; ensure consistent, quality data review, protocol deviation review, and coding review.
• Organize and perform study level and individual subject level analysis of clinical trial data to gain insights and develop strategies for clinical development and reporting.
• Participate in ongoing trial data reviews with medical teams and advisors to maintain data quality and integrity.
• Attend and contribute, as needed, at meetings with Health Authorities (HAs) related to program.
• Develop responses to HAs and IRBs on clinical/medical questions.
• Contributing to or performing therapeutic area/indication research and competitor analysis.
• Develop and optimize an effective KOL and investigator network to support the CDP.
• Work with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose.
• Mentor, coach, and manage other Clinical Scientists based on future organizational structure and business needs.
• Handle additional tasks as required to support project needs.

Personal Qualities:

• The successful candidate will be a confident person keen to take responsibility for assigned activities. Although working under the guidance of a manager and the clinical leader of the program, the Director/Senior Director will be expected to function largely independently and would thrive in a mentored rather than a directed environment.
• The Director/Senior Director will be able to take on new and varied activities and will enjoy participating at every level of the project, ranging from detailed review of documents/data through to strategic program planning. They will be committed to working within a project team structure, will be an excellent negotiator and will be able to manage other functions through a matrix structure.
• The Director/Senior Director will feel comfortable presenting data to peers, investigators and senior management/executive committee. They will be able to embrace the challenges and opportunities offered in a small company environment and to capitalize on the experience.

Minimum Requirements:

• A minimum of 8 years of relevant experience and an advanced clinical/science degree (PharmD, MSN, MPH, PA, MBBS, MD, etc.) are required. For consideration for a Senior Director role, a minimum of 12 years of experience in a similar role is needed.
• Previous participation in a clinical development program is essential, preferably involvement in all stages of clinical trials (i.e., from start up to study report).
• Experience in clinical trials with small molecules preferred.
• Strong therapeutic expertise in oncology is required.
• Experience working in a small, resource constrained startup environment is required.
• Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
• Proficient knowledge and skills to support program specific data review, trend identification, and data interpretation.
• Knowledge of the establishment and operation of data monitoring committees and independent response adjudication committees.
• Excellent leadership and project management skills; able to prioritize multiple tasks and goals and deliver them in a timely, on-target, and high-quality manner within budget guidance.
• Excellent interpersonal, verbal communication, and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders both internally and externally.
• Strong presentation skills; effective at summarizing and presenting the key considerations and decision-points.
• Excellent teamwork and negotiation skills; able to complete deliverables by working effectively with others internally and externally and can effectively drive discussions and decisions toward desired end-results.
• Enjoy operating in an exceptionally dynamic, high-achieving and cooperative environment where every voice matters.
• Demonstrated willingness to lead, champion, and operate with Circle's Core Values.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g.,Medidata/RAVE) or similar data reporting tools.
• Domestic and international travel may be required (approximately 10-20%)

$205,000 - $279,000 a year

The expected salary for a Director in this role in South San Francisco, CA is $205,000 - $241,000, and for Sr. Directors, it is $237,000 - $279,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, Circle's internal pay equity, etc.

Circle Pharma recognizes that the success of our endeavors depends on the success of every team member. Your well-being is our top priority, and we are proud to offer a comprehensive total rewards package. Our benefits include but are not limited to medical, dental, and vision care. We also provide a 401(k) plan with a generous company contribution, and all of our offers contain a stock option component. We provide company-paid life insurance, short-term and long-term disability. Additionally, we provide many company-paid holidays, including a winter break at the close of the calendar year. 

 

Circle Pharma is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, gender identity, disability status, membership in an organization or any other non-merit factors.