Head of Global Clinical Development

Regulatory Jobs; Waltham (MA); Hybrid; USD 400,000 - 425,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics in Waltham, MA seeks a seasoned Head of Clinical Development to lead the global medical evidence strategy and execution for obesity therapies. The role involves cross-functional leadership, external scientific collaboration, and regular interaction with global regulators.

The position requires extensive clinical development experience, late-stage program leadership, and a strong track record in regulatory interactions.

Qualifications

• At least 15 years of clinical development experience with proven track record of executing clinical trials and global regulatory interactions.
• Significant late-stage development experience across large-scale, complex programs.
• Experience in obesity and/or metabolic disease strongly preferred.
• Exceptional cross-functional communication skills, with the ability to influence and lead across diverse stakeholders.
• Prior leadership, budgeting and resource management experience required.
• Uncompromising ethics, passion for teamwork and people, attention to detail, solution focus, and strong communication skills.
• Ability and willingness to fly at necessary altitude to get job done.
• A drive for problem solving, continual learning, and attracting, mentoring, and retaining best people.
• Local candidates are strongly preferred; relocation and remote talent will be considered. Remote employees must adhere to the Hub & Home working model, including a minimum of one week per month in the Waltham, MA corporate office (in addition to any other work-related travel), with overall work-related travel estimated at least 25%.

Responsibilities

• Build, grow, and lead the global clinical development organization
• Develop and execute global development strategy and resultant evidence generation plan with incorporation of cross-functional and regional input
• Design, execute, complete, and communicate clinical trials (eg, scientific advisory boards, protocol development, regulatory and ethic committee interactions, medical monitoring, data analyses, study reports, regulatory correspondences and filings, presentations, and data dissemination)
• Deliver robust clinical trial data on-time and on-budget to inform product benefit: risk
• Interface with global medical opinion leaders in obesity to inform clinical development program and maintain engagement
• Clear, data-based, patient-focused communications with global regulators
• Provide clinical input to regulatory, safety, medical affairs, commercial, payer, and manufacturing colleagues

Skills

Cross-functional leadership

Global regulatory interactions

Stakeholder communication

Budgeting & resource management

Ethics & teamwork

Problem solving & continual learning

Education

MD or equivalent

Job description

Kailera Therapeutics in Waltham, MA seeks a seasoned Head of Clinical Development to lead the global medical evidence strategy and execution for obesity therapies. The role involves cross-functional leadership, external scientific collaboration, and regular interaction with global regulators.

The position requires extensive clinical development experience, late-stage program leadership, and a strong track record in regulatory interactions.