SR. MEDICAL DIRECTOR, EARLY CLINICAL DEVELOPMENT /

 

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, .

 

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, Head of Early Development, the Sr Medical Director, Early Clinical Development/Executive Medical Director, Global Development Lead will oversee the early clinical development of CID-078. In this critical role, you will be responsible for the operational execution of the CID-078 clinical development program, from early-stage studies through proof of concept and potentially to commercialization. This position will have accountability for medical monitoring, analysis, and reporting of studies. You will play a pivotal role in driving the development of breakthrough therapies for patients. 

 

In addition, this individual will play a leadership role in the Clinical Development team and mentor or manage others in the Clinical Development and Clinical Science function. This position must play a leadership role in the identification and evaluation of efficacy, safety, and biomarker clinical issues within and across the clinical program(s). This position may also have supervisory responsibility for other physicians and clinical scientists and may have accountability for building the CID-078 clinical team. This position may evolve to see CID-078 through later stage development, NDA/MAA submission, and possible commercialization. Alternatively, this position may handoff CID-078 late-stage development and remain within early development and have supervisory responsibility for other physicians and clinical scientists and may have accountability for building the early development clinical team.

Role Summary:

• • Support clinical trials and the development strategy for early development asset(s) and lead development program(s) across multiple functions within Circle Pharma, as well as represent the program with the external clinical community.
  • Provide medical monitoring for the CID-078 program and function as the Clinical Development representative on the cross-functional project teams (both internally and with external vendors/CROs).
  • Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans.
  • Ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
  • To support projects from Research to Proof of Concept (typically phase 3) development. Possibility to stay with molecule through phase 3 development.

Role Responsibilities:

• • Lead, develop and execute clinical development plan for early clinical asset(s).
  • Work across the organization and on multifunctional teams responsible for the development of early development assets (including Program Team).
  • Provide medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Oversee the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents (IND annual reports, briefing books, designation submissions, etc).
  • Work with Drug Safety/Pharmacovigilance in preparation / review of expedited safety report.
  • Provide leadership to early-stage clinical scientists on the clinical study team for Early Clinical Development, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists, drug safety/pharmacovigilance, clinical supply, and regulatory specialists. 
  • Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all Circle Pharma first-in-human clinical trials 
  • Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies for early development assets.
  • Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards.
  • Conduct literature reviews and prepare summaries to support clinical development programs.
  • Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.
  • Coordinate regular interactions with preferred clinical trials network and KOL advisory board to objectively consider and implement feedback.
  • Drive innovations in early clinical development, and the application of translational oncology and precision medicine approaches.
  • Collaborate with cross-functional leaders and teams to translate early preclinical discovery research into therapeutic candidates.
  • Coordinate with business development to establish strategic external collaborations and foster new research projects and programs.

Qualifications:

• • MD or MD-PhD with 5 years (Sr Medical Director) or 10 years (Executive Medical Director) of industry experience in oncology drug development.
  • Track record in early phase drug development is required.
  • Clinical oncology experience: Board certification in oncology preferred.
  • Significant industry leadership experience in clinical and translational medicine (Ex Medical Director).
  • Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, clinical pharmacology).
  • Experience in development of small molecules for solid tumors preferred.
  • Experience working in a small, resource constrained startup environment is required.
  • Demonstrated scientific productivity (publications, abstracts, etc.).
  • Proven scientific writing skills and good communication skills.
  • Proven leadership skills with ability to defend the clinical plan at governance meetings is essential.
  • Capacity to adapt to a fast-paced and changing environment.
  • Demonstrated history of effective leadership; including cross functional and matrixed teams, managing direct reports, and experience in seeking and maintaining alignment with cross-functional leaders.
  • 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%).
  • Have a passion for helping patients with cancer and for the science of oncology.

Preferred Qualifications:

• • Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders.
  • Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
  • Is a team player, works well in a team environment both as a leader and a key contributor.
  • Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds, and geographies.

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, the Senior Medical Director/Executive Medical Director will be expected to function largely independently and would thrive in a mentored rather than a directed environment.
  • The Senior Medical Director/ Executive Medical 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 Senior Medical Director/Executive Medical 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.

$288,000 - $373,000 a year

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.