Vice President, Head of CMC - Circle Pharma, Inc.

Circle Pharma is a dynamic biotech company advancing the discovery and development of cell-permeable oral macrocycles. Our platform combines structure-based drug design and advanced synthetic chemistry to create first-in-class macrocycle therapeutics for severe unmet clinical needs. We are focusing our development efforts on cyclins, which are master regulators of the machinery that controls progression of cells through the cell cycle and are key drivers in many cancers.

We seek passionate individuals poised to drive our growth and make a difference. Learn more about Circle Pharma at 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 Vice President and Head of CMC will provide strategic leadership and ultimate oversight for all drug substance and drug product development activities at Circle Pharma. This role encompasses responsibility for CMC development, both GMP and non-GMP manufacturing, and the supply chain management of all drug substance and product, from clinical stages through to commercial supply.

Development activities and GMP manufacturing are conducted externally and overseen by a small internal team supported by external consultants. The Vice President, Head of CMC will lead this team, providing essential in-house CMC expertise. They should be well-versed in the common risks and bottlenecks associated with CMC development and external manufacturing while also being adept at resolving complex challenges to ensure a reliable and timely supply of clinical trial material.

Although daily on-site presence at Circle’s South San Francisco location is strongly preferred, this role can accommodate a hybrid work arrangement, to be determined by the hiring manager and the successful candidate.

• Provide operational and strategic leadership for starting materials, drug substances, and drug products, as well as overseeing both non-GMP and GMP manufacturing activities across all Circle Pharma programs, from preclinical stages through commercialization.
• Plan, align and establish a CMC team of in-house staff and external consultants, and oversee the hiring, training, and management of all in-house functions such as Quality (CMC), Regulatory CMC, Clinical Supply Chain Management, Analytical Development, and Process Development (DS + DP).
• Oversee management of existing CDMO/CMOs and selection of future CDMO/CMOs, analytical labs, or other suppliers.
• Ensure that partner CDMOs/CMOs meet specified standards, adhere to timelines and budget constraints, and comply with regulatory requirements.
• Align CMC Development with R&D and Clinical Development, planning and delivering all clinical supply.
• Establish all manufacturing processes and analytical methods to the right level based on development stage with appropriate tech transfer and establishment at CDMO/CMOs.
• Oversee the development of the Quality Management System (QMS) for the support of all CMC development work and required Quality oversight of all GLP and GMP activities relating to CMC.
• Provide CMC leadership for our research programs (formulation development, early compound scale up).
• Establish performance metrics and ensure full transparency by providing regular updates on all CMC Development and GMP manufacturing activities to Early Development teams, Senior Management, and Board Members as required.

• PhD in Chemistry, Pharmaceutical Sciences, or a related field with at least 15 years of pharmaceutical industry experience, specifically in small molecule CMC Development and GMP manufacturing. Candidates with a Master’s or Bachelor’s degree must have additional years of experience.
• Experience working with small molecules in an oncology setting is highly desired.
• Proven track record in strategic thinking and executing technical strategies.
• Demonstrated experience in leading CDMO relationships with a results-driven mindset and strong business acumen.
• Mixture of technical and managerial experience required, including a solid track record of managing multiple development projects.
• Extensive experience in establishing and leading diverse technical teams to achieve high-performance results in CMC Development, Technical Operations, Pharmaceutical Sciences, or Pharmaceutical Development.
• Excellent leadership skills with a proven ability to manage virtual CMC Development and GMP manufacturing teams at CDMOs/CMOs.
• In-depth knowledge of regulatory requirements for small molecule development and GMP manufacturing in the UK, Europe, and the US.
• Previous experience interfacing with Health Authorities for scientific advice, pre-submission meetings, and inspections.
• Experience in developing and overseeing regulatory submissions such as INDs, IMPDs, NDAs, and MAAs.
• Strong communication and presentation skills, with the ability to effectively explain technical matters to stakeholders in other disciplines.
• Excellent reputation and a well-established external network within the biopharma community.
• Experience working in a small, resource constrained startup environment is required.
• 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.

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.