Executive Director, Formulations and Drug Product Development

About The Company

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardioendocrine diseases. Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of leading life science investors including Sofinnova, Forbion, Xontogeny/Perceptive Advisors, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.

The company’s lead program, MAR
001, is a monoclonal antibody targeting ANGPTL4, a genetically validated target with potential to address the subset of patients at the highest risk of adverse cardiovascular events, despite current standard of care therapies. MAR
001 is rapidly progressing through Phase 2b clinical development. Our second clinical asset, MAR
002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR
002 has potential to become best-in-disease and is rapidly progressing through Phase 1 clinical development. We also have a third asset that is rapidly advancing through research discovery, with DC nomination expected next year. At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders.

Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is Hands-On, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

This is a key role within the first phase of hiring for our Technical Operations team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical development, with additional programs in discovery. This role will report to the CTO. The successful candidate will oversee formulation development, drug product development and manufacturing, transition from vials to prefilled syringe for all of Marea’s development programs.

Successful candidate will develop CMC strategy for formulation and drug product working cross functionally across other technical operations functions and also work closely with clinical development, clinical operations and program teams to ensure that the product profile and configuration is consistent with the target profile needed for the clinical study and ultimately for commercial launch. In addition to the strategic responsibilities, candidate will have operational responsibility to provide technical and day-to-day oversight of our CDMOs and other external partners conducting formulation and drug product development and own critical technical decisions around formulation selection and drug product presentations for the entire portfolio.

Candidate will also plan future tech transfer and drug product manufacturing strategy, develop and execute life cycle plans and ensure these are integrated into the cross functional project team as well as the financial operating plans. While the role is primarily focused on formulation and drug product development, this is a leadership role that is expected to influence and guide the overall CMC development especially considering that many of the CMC challenges for our portfolio products are centered on formulation and drug product.

The scope of the role will also include discovery programs, that are expected to approach drug candidate nomination, where the candidate is expected to provide molecular and formulability assessment, and biophysical characterization, to impact the selection of the candidate molecules. The role is also expected to contribute to drug product comparability and analytical characterization as part of the CMC life cycle management.

This role is viewed as a senior member of the technical operations team and will be a keep voice in guiding the evolution of the department with respect to CMC strategy and the growth of the team in anticipation of various strategic scenarios. As such, the scope of this role is expected to evolve accordingly.

This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.

• Accountable for formulation and drug product development strategy and execution for the entire Marea portfolio which includes monoclonal antibodies in early and late-stage CMC development and other modalities in discovery.
• Develop a holistic drug product, formulation and device strategy for each of Marea’s asset keeping in mind clinical/patient experience, commercial opportunity and regulatory considerations.
• Design/execute (with the…