Senior Medical Director, Clinical Development

Regulatory Jobs; Waltham (MA); On-site; USD 296,000 - 355,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus & equity

Job summary

Kailera Therapeutics, Inc. in Waltham, MA is seeking a Senior Medical Director, Clinical Development to design and lead clinical development programs for our obesity-focused pipeline. This role requires biotech experience, strong leadership, and the ability to drive cross-functional collaboration.

The position is on-site 3-4 days per week, with a competitive salary and comprehensive benefits. You will supervise medical monitoring, regulatory strategy, and scientific communications while

Qualifications

• 4+ years of industry experience in clinical development.
• Hands-on experience designing and executing clinical trials.
• Understanding of GCP, trial design, regulatory requirements, and safety monitoring.
• Excellent written and verbal communication for protocols and regulatory docs.
• Engages with KOLs, investigators, and cross-functional teams.
• Independent, self-starter with ability to manage multiple studies.
• Advanced PowerPoint; working knowledge of Excel and clinical systems/tools.
• Ability to meet tight deadlines in a fast-paced environment.
• Exceptional attention to detail.

Responsibilities

• Medical monitoring, reporting and safety activities.
• Provide strategic medical leadership in study design and execution.
• Serve as medical contact for clinical/medical issues.
• Interpret and present product research results.
• Act as medical expert for assets studies.
• Contribute to regulatory interactions and IND/CTA submissions.
• Collaborate with Clinical Operations on site selection and recruitment.
• Oversee data interpretation and clinical study reports.
• Collaborate with Regulatory, Safety, CMC, Medical Affairs, Translational Science.
• Drive partnerships with external collaborators and KOLs.
• Support publications, conferences and external communications.
• Participate in safety review meetings and adverse event input.

Skills

Clinical development

GCP knowledge

Regulatory understanding

KOL engagement

Cross-functional collaboration

Independent/self-starter

PowerPoint

Excel

Multitasking

Attention to detail

Education

MD or equivalent

Tools

Excel

Clinical systems/tools

PowerPoint

Job description

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 Senior 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 (hub-based, onsite 3-4 days per week)

Responsibilities:

• Responsible for medical monitoring/reporting and safety activities
• Provide strategic 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
• Serves 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, Medical Affairs, and Translational Science teams
• Drive partnerships 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:

• 4+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
• Hands-on experience designing and executing clinical trials
• 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
• Advanced PowerPoint skills; working knowledge of Excel and other commonly usedclinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment
• Must be exceptionally detail oriented

Preferred Qualifications:

• Experience in cardiometabolic therapeutic area is advantageous
• Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Education:

• MD or equivalent is required

Salary Range

$296,000—$355,000 USD

For Full Time Roles:

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.