Clinical Program Lead

Company Overview
TwoStep Therapeutics is at the forefront of innovation in cancer treatment, pioneering a multi-targeting platform aimed at advancing a pipeline of targeted therapies applicable to a wide range of solid tumors. Our mission is to transform cancer care by extending precision medicine to diverse tumor types and patient populations, particularly those with limited options. Founded by industry leaders including CEO Caitlyn Miller, Stanford Professors Jennifer Cochran, Ronald Levy, and Nobel Laureate Carolyn Bertozzi, TwoStep Therapeutics emerged from Stanford in March 2024 and is backed by NFX and other prominent biotech investors.

Position Overview
We are seeking a dynamic Clinical Program Lead to spearhead the delivery of our tumor-targeted therapies to patients. In this pivotal role, you will be responsible for the design and implementation of clinical stage programs, making this an exciting opportunity for a driven drug developer eager to influence the future of cancer treatment and enhance patient outcomes.

Key Responsibilities

• Lead clinical development activities within a cross-functional team, from early to late-phase clinical studies.

• Develop comprehensive clinical development plans and study designs, including the creation of study concepts, protocols, and essential regulatory documentation.

• Oversee and ensure timely execution of clinical trials.

• Establish and maintain relationships with Key Opinion Leaders (KOLs) and act as the primary clinical representative in all regulatory and external communications.

Essential Qualifications

• Master’s degree or equivalent in a related field, or a combination of education and relevant experience.

• 5+ years of experience in clinical development with a PhD or MD; 8+ years with a Master’s; 10+ years with a Bachelor’s degree.

• Extensive experience in both early and late-phase clinical development.

• Proficiency in authoring regulatory documents and a strong understanding of the drug development process.

• Solid grasp of clinical research methodologies and biostatistics principles.

• Comprehensive knowledge of FDA, EMA, MHRA, and ICH GCP guidelines.

• Exceptional attention to detail, a commitment to high-quality work, and a strong sense of urgency to achieve team objectives.

• Proven leadership in managing complex projects and a track record of delivering results.

• Excellent verbal and written communication skills.

• Strong analytical, problem-solving, and strategic planning abilities.

Preferred Qualifications

• Experience in clinical oncology drug development, particularly with tumor-targeted drug conjugates (e.g., peptide-drug conjugates, antibody-drug conjugates, etc.), immunotherapy, or radioligand therapy.

What We Offer
At TwoStep Therapeutics, we envision a future where every cancer patient has access to targeted, safe, and effective therapeutic options. We prioritize a diverse, inclusive work environment that fosters personal and professional growth. Our comprehensive benefits include:

• Competitive base salary and equity compensation

• Unlimited Paid Time Off (PTO)

• Comprehensive medical, dental, and vision benefits for individuals and families

• 401(k) plan

• Company-paid basic life insurance

Job title and compensation are dependent on the candidate’s experience and skillset.

Equal Opportunity Employer
TwoStep Therapeutics is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require assistance in submitting an application due to incompatible assistive technology or a disability, please contact us at hiring@twosteptx.com. We are committed to accommodating your needs promptly.

Join Us
If you are passionate about advancing cancer therapies and want to make a meaningful impact in the field, we invite you to apply for the Clinical Program Lead position at TwoStep Therapeutics. Together, we can shape the future of cancer treatment.