Kailera Therapeutics, Inc.
Medical Director, Clinical Development
Kailera Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
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: We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.
Required location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities:
Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators
Support scientific publications, conference presentations, and other external communications
Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting
Required Qualifications:
2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands‑on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross‑functional teams
Can work independently; self‑starter attitude
Preferred Qualifications:
Experience across multiple therapeutic areas, including obesity, is advantageous
Proven track record of contributing to BLA/NDA submissions is a strong plus
Education:
MD or equivalent is required
Benefits of Working at Kailera
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
Salary Range: $205,000 - $250,000 USD
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.
Kailera Therapeutics, Inc. uses E‑Verify to confirm the identity and employment eligibility of all new hires.
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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: We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.
Required location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities:
Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators
Support scientific publications, conference presentations, and other external communications
Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting
Required Qualifications:
2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands‑on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross‑functional teams
Can work independently; self‑starter attitude
Preferred Qualifications:
Experience across multiple therapeutic areas, including obesity, is advantageous
Proven track record of contributing to BLA/NDA submissions is a strong plus
Education:
MD or equivalent is required
Benefits of Working at Kailera
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
Salary Range: $205,000 - $250,000 USD
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.
Kailera Therapeutics, Inc. uses E‑Verify to confirm the identity and employment eligibility of all new hires.
#J-18808-Ljbffr