Senior Director, Pathology

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The candidate will be responsible for pathology assessment of multiple pipeline candidates in Kailera’s portfolio. This will include primary evaluation and peer review of histopathology specimens, clinical pathology, and associated data from toxicology studies. The candidate will integrate the data and author relevant sections of regulatory documentation, study reports and manuscripts. The candidate will also review scientific literature to prepare risk assessment documents for inclusion in regulatory and scientific documents such as pediatric development plans, carcinogenicity waivers, and target risk assessments. This will include development of mechanistic understanding of on and off target toxicology findings. You will represent the company at meetings with regulators and at conferences. The candidate is expected to be a key member of multidisciplinary project teams, ensuring safe and effective use of therapeutics in clinical trials and beyond.

Preferred location: Waltham, MA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Design, oversee, peer review and integrate pathology data from multiple toxicology studies
• Lead risk assessment of any findings in the context of clinical trials, in particular assessment of biological mechanisms of toxicity and comparison with other agents of the same class
• Author relevant sections of scientific and regulatory documents to an excellent standard to ensure seamless approval of relevant clinical trials
• Develop a deep understanding of relevant biology to enable scientific risk assessments and submission of regulatory documents such as carcinogenicity waivers and pediatric development plans
• Represent the department on multidisciplinary project teams such that drug candidates are developed rapidly and efficiently
• Provide advice and support to departmental senior leadership and be a visible advocate for the department across the company

Required Qualifications:

• At least 10 years of experience in drug development within industry
• Demonstrated excellence in evaluating anatomic pathology findings in multiple study types and species
• Demonstrated excellence in communication (written and oral)
• Ability and desire to take on leadership roles within the department and cross functionally
• Strong decision-making, complex problem solving, critical data analysis and interpretation.
• Demonstrated excellence working as a project team representative, driving forward drug development in a cross functional environment
• Ability to thrive in a fast-paced environment and comfort with ambiguity

Preferred Qualifications:

• Experience in developing drugs in the cardiometabolic field – particularly incretin therapies

Education:

• PhD in a related field
• DVM (or equivalent)
• Board certified by the American College of Veterinary Pathologists (ACVP), European College of Veterinary Pathology (ECVP) and/or Japanese College of Veterinary Pathology (JCVP)

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

 #LI-Hybrid