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Medical Director, Clinical Development

Cambridge, Massachusetts, United States

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation – debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases.  Despite the availability of multiple approved medicines, there is an urgent need for new treatment options.  We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles – and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important.  Bring your full self to work and create space for others to do the same.  Balance candor with empathy.

 

Own the Big Picture

Context is critical.  Ground every decision and action in the entirety of what we are trying to achieve.

 

Go THRD

We hold ourselves to a higher standard.  Work with urgency, purpose, and passion.

 

The Role

Reporting to the Senior Vice President, Clinical Development, the Medical Director will serve as the medical lead for one or more development program(s), providing medical oversight of the design, implementation, and monitoring of clinical trials as well as the analysis and reporting of clinical trial results. This role involves cross-functional collaboration to develop and implement long-term strategic plans, crucial for advancing our clinical development programs in the field of Allergy and Inflammation.

Responsibilities

  • Participate, primarily, in activities related to phase 1-4 clinical trials
  • Provide medical oversight and input into the design and review of key study documents, including; protocols, investigator brochures, informed consent forms and clinical study reports
  • Serve as the medical monitor of clinical trials, participate in medical safety review committees, provide medical input into regulatory documents and, when requested, represent the medical function during regulatory interactions  
  • Partner with Research, Regulatory Affairs, Non-Clinical Science, and Medical Affairs to ensure timely and effective clinical and scientific input into overall program
  • Participate in investigator meetings and site initiation visits with clinical trial investigators, and partner with Clinical Operations and Medical Affairs in driving enrollment into the clinical studies
  • Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities
  • Study Data Review and Analysis
    • Provide medical input into statistical planning and ensure data analysis and interpretation are clinically relevant.
    • Perform ongoing review and analysis of emerging study data
  • Provide medical leadership as needed for clinical issues that may arise during clinical trial execution
  • Provide medical oversight and support for publication of data (manuscripts, posters, etc.) and, as appropriate, other related scientific publications
  • Partner with medical affairs to develop strategic partnerships with thought Leaders
  • Review adverse events, monitor trial safety, conduct thorough medical reviews of individual case safety reports (ICSRs), and support analyses for regulatory submissions
  • Contribute to the development of commercial materials and participate in commercially focused activities

Required Qualifications

  • Medical Degree (MD/DO) with certified fellowship training in Allergy and Immunology (other subspecialty training relevant to the immunology & inflammation space will be considered)
  • Expert on disease characterization based on biomarkers and line of treatments
  • 3+ years’ biotechnology/pharmaceutical relevant experience as a medical lead within clinical drug development (early-stage development through approval)
  • Experience designing and developing clinical protocols and managing trials associated with US or EU regulatory oversight
  • Demonstrate attention to detail; possess ability to express ideas clearly and accurately
  • Willingness to travel ~20-30%, including occasional international travel

Preferred Qualifications

  • Prior management experience, successfully managing other development/clinical research professionals
  • Real world experience with patient care/management

The approximate salary range for this role is $300,000-$344,000.

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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