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Chief Development & Strategy Officer

New York, NY

About the job


Company Background:

Gilgamesh Pharmaceuticals is a clinical stage biopharmaceutical company aspiring to deliver innovative therapeutics to address the unprecedented unmet need for improved mental health treatments.Research to date for NMDA receptor antagonist and 5HT2A receptor agonist prototype molecules has revealed exciting efficacy outcomes and shows promise to be a true leap forward in allowing people to achieve more enjoyable, fulfilled lives. Key therapeutic indications under investigation include MDD, Bipolar Disorder, Substance Use Disorder, OCD and other neuropsychiatric disorders. All Gilgamesh programs are entirely new proprietary chemical entities.


Job Description:

The Chief Development and Strategy Officer (CDSO) will play a pivotal role in shaping the strategic direction and execution of our clinical development programs in close collaboration with the CMO. Reporting directly to the CEO, the CDSO will be responsible for leading our efforts from pre-clinical research through to clinical trials and regulatory approval. This role demands a leader who is adept at navigating the complexities of drug development in the neuroscience field.


Responsibilities:

  • Develop and implement strategic plans for clinical development, including defining the roadmap for all phases of clinical trials in collaboration with the CMO.
  • Collaborate with the R&D team to integrate translational science approaches into clinical development strategies.
  • Lead interactions with regulatory bodies, including the FDA and EMA, and ensure all clinical development activities align with regulatory strategies.
  • Collaborative Leadership: Collaborating with functional team leaders, the CDSO fosters alignment across the different sub -teams to ensure alignment (Clinical, Commercial, Regulatory, Clinical Operations, CMC, Toxicology and other key team members)
  • Triage and Risk Management: Serving as a point of triage, the CDSO facilitates clear decision-making by incorporating cross-functional input to address high-impact issues. This involves co-creating solutions to complex challenges in real time.
  • Decision Leader: The CDSO leads the Program Strategy Team in framing program needs and develops a range of options and recommendations for presentation to Gilgamesh leadership. CDSO ensures transparent communication with senior leadership, highlighting relevant scenarios, assumptions, and risks to inform decision-making and trade-offs.
  • Drive partnerships with academic, industry, and clinical research organizations to advance our programs.
  • Provide expert guidance on psychiatric disorders and their treatment to align our product development with current and emerging needs in mental health care.
  • Able to consider and communicate various aspects of development strategy including Commercial, Regulatory, Clinical, Investor and other key perspectives
  • Communicate progress and challenges to Investors, the board of directors and other stakeholders with transparency and strategic insight.


Requirements:

  • Advanced degree (MD or PhD) in Psychiatry, Clinical Psychology, Neuroscience, or a related field.
  • Minimum of 20 years of experience in pharmaceutical or biotechnology industry, with a significant focus on CNS/psychiatry drug development.
  • Proven track record of leading successful clinical trials and achieving regulatory milestones.
  • Strong leadership skills from leading cross-functional teams in a matrix organization, with highly collaborative instincts and a track record of resolving conflicts within the team
  • Deep understanding of the scientific and clinical aspects of psychiatric disorders.
  • Ability to communicate clearly and effectively with Investors, Board of Directors, clinical scientists, biologists, manufacturing experts, as well as with regulatory and commercial colleagues
  • Strategic thinker with the ability to anticipate future trends and challenges in neuroscience drug development.
  • IPO and public company experience strongly preferred.


We offer a competitive salary, equity, benefits package, and opportunities for professional growth and development.


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