Executive Director, Medical Affairs

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

The Executive Director, Medical Affairs will collaborate with cross-functional teams, key opinion leaders (KOLs), and other stakeholders to ensure the successful implementation of medical affairs strategies. This role will drive the company's efforts in Medical and Scientific Communications (Publications/Data Dissemination), guide a US & Global KOL engagement Strategy, and partner closely with THRD program teams to ensure key medical affairs value drivers are incorporated into target product profiles and clinical development plans.

Responsibilities

• Build strategic medical communications and evidence-based content and information resources in collaboration with the SVP Clinical Development and the Development Teams.

• Lead and execute a core medical and scientific communication strategy including the management of appropriate vendors

• Collaborate with internal and external stakeholders to develop a plan for the generation and dissemination of scientific and clinical data consistent with the core communication strategy

• Manage communication strategy, scientific exchange and coverage for specific medical or scientific congresses.

• Drive engagement and collaboration with internal and external stakeholders to enhance core communication strategy and serve as a central contact and facilitator for medical affairs related activities.

• Provide oversight of publications and other externally facing medical and scientific communications, ensuring information is sound and accurate.

• Participate in the generation and/or review of target product profiles and clinical development plans to ensure trial designs and clinical outcomes incorporate the key commercial stakeholders including health insurers and Health Technology Assessment (HTA) Organizations.

• Participate in reviewing and analyzing trial insights, assess investigator-sponsored study (ISS) requests and provide a Medical Affairs perspective on pipeline and lifecycle strategies.

• Identify internal and external educational needs and create/execute educational efforts (i.e., Speakers, Forums, Symposiums) to address needs in support of medical affairs strategy

• Incorporate the patient perspective, and strategic insights from patient advocacy groups and look for new ways to inform and influence strategy from discovery to clinical development and eventually commercialization. This will include the establishment, planning, and execution of Patient Advisory Boards

• Manage the development and oversight of the medical affairs budget, ensuring resources are available to execute on key short- and long-term initiatives

• Ensure all medical affairs activities are in compliance with internal THRD policies, procedures and SOPs as well as industry and regional regulations.

Minimum Qualifications

• MD, PharmD, or PhD with minimum 15 years of related experience, including 5 years in pharma industry with relevant Medical Affairs strategy experience (2-3 years' experience in pre-approval setting)

• Strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance.

• Demonstrated ability to present complex scientific and medical information to a range of audiences; ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and approach.

• Experience in Immunology, allergy, and inflammation.

• A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices

• Knowledge of clinical trial design, biostatistics

• Strong knowledge of US PhRMA, and appropriate regulatory bodies & guidelines relating to compliant medical engagements

• 25-40% travel required for this role

Desired Qualifications

• Self-directed individual with the ability to multi-task effectively and deliver results on time. Enterprise mindset

• Excellent communication skills with an ability to develop collaborative relationships and work effectively with all levels of management.

• Strategic mindset with ability to identify & create solutions to various scenarios.

• Proven ability to develop and grow productive relationships with external and internal stakeholders in a range of disciplines.

• Strong organizational skills & ability to deal with competing priorities.

• Strong reasoning & creative solving skills

The approximate salary range for this role is: $290,000 - $320,000

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.