Senior Director, Clinical Development

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COMPANY OVERVIEW
Pretzel Therapeutics is a biotechnology company headquartered in Boston, Massachusetts, with research facilities in Mölndal at GoCo House, part of GoCo Health Innovation City. Pretzel Therapeutics is dedicated to developing life-changing medicines with a broad pipeline of first-in-class treatments addressing novel targets within the mitochondria. By harnessing cellular energetics to modulate disease processes and improve survival, function and quality of life, we are ushering in a new treatment paradigm for a breadth of conditions spanning neurological, muscle, metabolic and rare diseases.

POSITION SUMMARY
The Senior Director, Clinical Development serves as a strategic and scientific leader responsible for advancing Pretzel’s clinical programs from first-in-human studies through late-stage clinical development. This individual will design and execute robust Clinical Development Plans, lead cross-functional teams, and ensure clinical programs are aligned with the company’s scientific vision and regulatory strategy. As the clinical lead for one or more programs, this leader will oversee protocol development, medical monitoring, safety assessment, and data interpretation, while helping shape portfolio strategy and representing the clinical perspective to internal governance, investigators, partners, and global health authorities.

KEY RESPONSIBILITIES

• Serve as Clinical Lead for assigned programs spanning Phase I–III development, ensuring strategic coherence and scientific rigor.
• Develop, maintain, and execute integrated Clinical Development Plans aligned with corporate goals and program maturity.
• Design innovative, globally competitive clinical trial strategies that incorporate translational insights, biomarkers, and patient-centered endpoints.
• Lead authorship of clinical protocols, amendments, investigator brochures, and review of statistical analysis plans.
• Provide clinical expertise to shape Target Product Profiles, label-enabling strategies, and regulatory roadmaps.
• Provide medical oversight for ongoing trials, including safety signal detection, benefit–risk assessments, and participation in Safety Review and Data Monitoring Committees.
• Partner closely with Clinical Operations to ensure operational excellence, feasibility, and timely execution of clinical studies.
• Interpret clinical and translational data and lead development of clinical study reports, publications, abstracts, and scientific presentations.
• Contribute to regulatory submissions including INDs, CTAs, briefing packages, and participate in interactions with FDA, EMA, and other global agencies.
• Support due diligence activities, external collaborations, and strategic partnerships as needed.
• Identify and mitigate clinical development risks across programs; contribute to portfolio prioritization and strategic decision-making.
• Support resource planning, budgeting, and development of scalable clinical processes aligned with Pretzel’s growth.

EXPERIENCE & QUALIFICATIONS

• Bachelor’s degree in a scientific discipline required; advanced clinical or scientific degree (MD, PhD, PharmD) strongly preferred.
• 10+ years of clinical development experience within the biotechnology or pharmaceutical industry.
• Proven leadership across early and/or mid-stage development programs, including experience serving as Clinical Lead or Global Clinical Lead.
• Strong understanding of global regulatory requirements (FDA, EMA, MHRA, PMDA) and experience contributing to regulatory submissions.
• Demonstrated ability to integrate complex clinical, pharmacologic, and translational data to inform development strategy.
• Therapeutic experience in rare diseases, genetic medicine, or mitochondrial biology strongly preferred.
• Strategic thinker with the ability to balance scientific excellence, clinical feasibility, and organizational priorities in a resource-conscious environment.

BENEFITS
Pretzel offers a highly competitive compensation package, including base salary, annual bonus eligibility, incentive stock options, comprehensive health, dental, and vision coverage, 401(k), paid time off, company holidays, and an annual winter shutdown.

TO APPLY

• Please upload your resume, titled with your full name (Ex. “Susan Davis_Resume”)
  • Links to google drives and LinkedIn etc., will not be accepted
• Place the Job Title in the email subject line
• Email: careers@pretzeltx.com

RECRUITMENT NOTICE
The Human Resources department is the sole authorized function responsible for all recruitment activities at Pretzel. No employee or representative outside of Human Resources is authorized to engage with, respond to, or establish relationships with external recruiting agencies.
Pretzel maintains relationships with a select group of approved recruiting partners. As such, Pretzel does not accept unsolicited outreach, candidate submissions, or resumes from external recruiters or agencies under any circumstances.
Any candidate information submitted without a prior written agreement executed by an authorized representative of Pretzel Human Resources will be considered unsolicited, will not be reviewed, and will not establish, imply, or create any contractual relationship or obligation, including any obligation to pay fees.
External recruiters and agencies are expressly prohibited from contacting Pretzel employees regarding open roles or candidate introductions. Any such outreach is considered a violation of Pretzel’s recruitment policy and will not be acknowledged or engaged.