Halda Therapeutics is a New Haven CT based venture-backed biotechnology company focused on the development of a novel heterobifunctional small molecule platform technology as an anti-cancer therapeutic modality. Halda was founded in 2019 by Professor Craig Crews (Yale University) and is funded by top-tier venture capital firms, raising $51M for a Series B round in December 2021.

The successful candidate will be responsible for carrying out the timely execution of IND-enabling and managing clinical development timelines for our oncology assets. This role will provide program management activities to track and drive interdependencies across preclinical, CMC, clinical and regulatory functions. She/He will manage vendors, consultants, and CROs ensuring high quality, and timely execution of early development activities. We are looking for a self-starter who thrives in the fast-paced, collaborative biotech environment.

Roles and Responsibilities:

• Perform the program management function to build program plans, identify risks and mitigation strategies, and manage budgets and timelines
• Track IND-enabling studies and the preparation of the IND modules, clinical protocols, and any updates/amendments/minutes and FDA/EMA interactions
• Participate in the creation of timelines that track the execution of integrated strategic development plans and scenario planning
• Provide operational leadership to an internal/external cross-functional team that will include representatives from research, clinical, nonclinical, regulatory, and CMC
• Oversight of development, manufacturing, and clinical CROs and consultants
• Oversee protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders and consultants
• Assure the quality of all deliverables and build best practices for efficient program teams
• Work closely with senior leaders to align the programs with the business objectives and mission

Knowledge and Skills:

• Experience in small molecule oncology drug discovery, including the transition of novel small molecule candidates from preclinical to clinical development
• Familiarity and understanding of early clinical trial design and regulatory requirements
• In-depth understanding of clinical product development
• Solid understanding of FDA, EMA, and other relevant regulatory guidance in drug development
• Excellent written, interpersonal, and public speaking skills
• Demonstrated ability to work in a matrix environment with cross-functional teams

Education and Experience:

• Advanced degree (M.S., M.D./Ph.D. or equivalent) and a minimum of 5 years of pharma/biotech industry experience
• Experience developing regulatory documents and strategy
• Experience in vendor and alliance management
• Experience in at least one of the functions related to pharmaceutical development (e.g. Research, Regulatory Affairs, Clinical Dev/Operations, CMC)
• Track record of compiling INDs successfully
• PMP certification is a plus

Job Type: Full-time

COVID-19 considerations:
Our labs are open at Halda Therapeutics, and all of the appropriate safety protocols from the State of CT and CDC are being implemented. Compliance with Mandatory Vaccination Policy required.

Job Type: Full-time

Pay: $189,000.00 - $224,974.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
Our labs and offices are fully open. We have implemented all of the appropriate safety protocols from the State of CT and CDC to keep our employees safe, including face coverings (as mandated by the City of New Haven) and a Mandatory Vaccination Policy.

Work Location: One location

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