Senior Director, Clinical Pharmacology

divh2Senior Director, Clinical Pharmacology/h2pAt 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 Kaileras 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./ppWhat Youll Do:/ppThe 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 Kaileras therapeutic candidates./ppRequired location: Waltham, MA (hub-based, onsite 3-4 days per week)/ppResponsibilities:/pulliDevelop, implement, and/or supervise clinical pharmacology strategies to drive Kaileras programs through all the stages, from research to Phase 3/liliServe as the clinical pharmacology lead on project teams, providing subject matter expertise/liliWork collaboratively with functional partners, including clinical development, biostatistics, translational medicine, CMC, toxicology, clinical operations, and regulatory to deliver project and corporate objectives/liliEnsure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase/liliAdvocate and represent clinical pharmacology, PK/PD, and model-informed drug development/liliDevelop the clinical pharmacology package, including dose selection and optimization/liliContribute to the development of regulatory documents (e.g. clinical protocols, INDs, NDAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions/liliBuild a culture of collaboration, innovation, and accountability within the team/liliPartner with translational medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies/li/ulpRequired Qualifications:/pulli10+ years of experience in clinical pharmacology in the biotech or pharmaceutical industry/liliProven track record of supporting drug candidates at various stages of development within the clinical pharmacology function/liliStrong expertise in pharmacokinetics, pharmacodynamics, and model-informed drug development strategies/liliComprehensive knowledge of global regulatory requirements for clinical pharmacology and experience contributing to regulatory submissions (IND, NDA, BLA)/liliPrior experience in diabetes, obesity, or related metabolic diseases is highly preferred/liliExcellent leadership and cross-functional collaboration skills, with the ability to influence and drive strategy across teams/liliExceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse stakeholders/li/ulpPreferred Qualifications:/pulliSubmission of IND/NDA/BLA and global marketing applications/liliExperience leading regulatory interactions related to clinical pharmacology strategies/liliExpertise in diabetes, weight management, or related metabolic diseases/li/ulpEducation:/pulliPhD or PharmD in a relevant scientific discipline (e.g. clinical pharmacology)/li/ulpSalary Range/pp$210,000 - $270,000 USD/ppThis range represents the companys 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 grantsbecause your well-being and future matter to us./ppEqual Employment Opportunity Information:/ppKailera 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./ppE-Verify:/ppKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires./p/div