Kailera Therapeutics, Inc.
Senior Director, Clinical Pharmacology
Kailera Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
What You’ll Do:
The Senior Director, Clinical Pharmacology will report to the Vice President, Translational Medicine and will be responsible for the design, execution, and interpretation of clinical pharmacology studies and strategy to support development programs in patients with obesity-related diseases. The Senior Director, Clinical Pharmacology requires strong scientific, technical, and leadership skills to develop and implement clinical pharmacology strategies to advance drug candidates across various stages of development. Working closely with cross‑functional partners, the individual is responsible for providing strategic and technical subject matter expertise and scientific oversight for the clinical pharmacology support of Kailera’s therapeutic candidates.
Required location: Waltham, MA (hub‑based, onsite 3-4 days per week)
Responsibilities:
Develop, implement, and/or supervise clinical pharmacology strategies to drive Kailera’s programs through all the stages, from research to Phase 3
Serve as the clinical pharmacology lead on project teams, providing subject matter expertise
Work collaboratively with functional partners, including clinical development, biostatistics, translational medicine, CMC, toxicology, clinical operations, and regulatory to deliver project and corporate objectives
Ensure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase
Advocate and represent clinical pharmacology, PK/PD, and model‑informed drug development
Develop the clinical pharmacology package, including dose selection and optimization
Contribute to the development of regulatory documents (e.g. clinical protocols, INDs, NDAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
Build a culture of collaboration, innovation, and accountability within the team
Partner with translational medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies
Required Qualifications:
10+ years of experience in clinical pharmacology in the biotech or pharmaceutical industry
Proven track record of supporting drug candidates at various stages of development within the clinical pharmacology function
Comprehensive knowledge of global regulatory requirements for clinical pharmacology and experience contributing to regulatory submissions (IND, NDA, BLA)
Prior experience in diabetes, obesity, or related metabolic diseases is highly preferred
Excellent leadership and cross‑functional collaboration skills, with the ability to influence and drive strategy across teams
Exceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse stakeholders
Preferred Qualifications:
Submission of IND/NDA/BLA and global marketing applications
Experience leading regulatory interactions related to clinical pharmacology strategies
Expertise in diabetes, weight management, or related metabolic diseases
Education:
PhD or PharmD in a relevant scientific discipline (e.g. clinical pharmacology)
Salary Range: $210,000 - $270,000 USD
This range represents the company’s good‑faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year‑end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well‑being and future matter to us.
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.
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Required location: Waltham, MA (hub‑based, onsite 3-4 days per week)
Responsibilities:
Develop, implement, and/or supervise clinical pharmacology strategies to drive Kailera’s programs through all the stages, from research to Phase 3
Serve as the clinical pharmacology lead on project teams, providing subject matter expertise
Work collaboratively with functional partners, including clinical development, biostatistics, translational medicine, CMC, toxicology, clinical operations, and regulatory to deliver project and corporate objectives
Ensure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase
Advocate and represent clinical pharmacology, PK/PD, and model‑informed drug development
Develop the clinical pharmacology package, including dose selection and optimization
Contribute to the development of regulatory documents (e.g. clinical protocols, INDs, NDAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
Build a culture of collaboration, innovation, and accountability within the team
Partner with translational medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies
Required Qualifications:
10+ years of experience in clinical pharmacology in the biotech or pharmaceutical industry
Proven track record of supporting drug candidates at various stages of development within the clinical pharmacology function
Comprehensive knowledge of global regulatory requirements for clinical pharmacology and experience contributing to regulatory submissions (IND, NDA, BLA)
Prior experience in diabetes, obesity, or related metabolic diseases is highly preferred
Excellent leadership and cross‑functional collaboration skills, with the ability to influence and drive strategy across teams
Exceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse stakeholders
Preferred Qualifications:
Submission of IND/NDA/BLA and global marketing applications
Experience leading regulatory interactions related to clinical pharmacology strategies
Expertise in diabetes, weight management, or related metabolic diseases
Education:
PhD or PharmD in a relevant scientific discipline (e.g. clinical pharmacology)
Salary Range: $210,000 - $270,000 USD
This range represents the company’s good‑faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year‑end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well‑being and future matter to us.
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.
#J-18808-Ljbffr