Chief Medical Officer

Job Description

Chief Medical Officer

Protego Biopharma, Inc. is a privately held biotech focusing on the discovery and development of first- or best-in-class small-molecule therapeutics that aim to reprogram protein folding for the treatment of various systemic amyloid diseases, such as light chain (LC) amyloidosis.

Protego’s technology tackles the protein misfolding problem through modulation of the energetics of protein or protein complexes by binding to small molecules such as pharmacological chaperones and/or by modulation of the cellular folding, secretory, and stress pathways.

Protego’s approach builds on the proven pharmacological chaperones approach previously exemplified by tafamidis, discovered and developed by our cofounders Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, for the treatment of transthyretin amyloidosis. The company also builds on the concept of correcting pathologic imbalances in protein homeostasis by specifically activating the unfolded protein response (UPR) with small molecules, to increase cellular folding capacity.

We are actively recruiting a Chief Medical Officer to oversee and lead the medical strategy and operational execution for our upcoming clinical programs. Reporting to the CEO, the Chief Medical Officer will have executive oversight across Clinical Development, Clinical Operations, Safety while also serving as a critical executive leader cross-functionally to R&D, BD / Corporate Development, etc.

As a key member of the Executive Committee, the CMO enables superior results for patients through discussions and decisions that focus on execution, developing capabilities, problem-solving and developing people and our culture, while embedding compliance in all activities.

The CMO will be the medical leadership face and voice of Protego Biopharma to various external constituencies, including healthcare professionals, regulatory authorities and patient organizations.

Key Responsibilities

• Lead the clinical research and development team advancing our therapies from pre-clinical to clinic, and lead development of clinical strategies
• Lead clinical aspects of regulatory strategies and interactions with regulatory authorities in the US and ex-US
• Designs and executes the strategy of GCP clinical trials, including the analysis and interpretation of clinical trial data, to support product registration in the US and international health authorities
• Leads communication of clinical program results both internally and externally
• Lead interactions with thought leaders, investigators, investors, regulatory agencies, critical stakeholders, partners and collaborators
• Work with the executive leadership team to develop long-term strategy, portfolio prioritization, new target selection and key areas of focus
• Engage patient advocacy groups across key focus areas
  
  

Position Requirements

• An MD degree is required for this role
• This position requires a minimum of 10 years in pharmaceutic industry with demonstrated success in clinical research and development, including translation from non-clinical to early clinical, registrational program design and execution
• Experience in designing and/ or conducting PoC studies, especially for orphan diseases
• Strong command of the drug development process, regulatory regulations and guidelines, and legal and compliance regulations, including GCP and ICH guidelines is required
• Preferred broad therapeutic area experience across Cardiovascular, Renal and Metabolic and rare disease drug development
• Exemplary leadership qualities with broad and formal leadership experience, including the ability to build and develop a high-performing organization/team and lead cross-functional collaboration is required
• Outstanding stakeholder management with the demonstrated ability to engage in close communication and foster effective decision-making is required
• Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, media, and internal audiences, including senior leadership is required
• A track record of driving innovation and organizational transformation is required, particularly within the environment of a small to mid-sized biotech company[DG1]
• Experience and a track record of working on first-in-class therapeutics
• Ideal candidate would be based in San Diego, CA