Senior Clinical Trial Manager / Associate Director
Dianthus Therapeutics, Inc.
Google Cloud Platform
Senior Director, Clinical Scientist – Respiratory
Generate Biomedicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $213,000 - $320,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as the clinical science lead across the respiratory portfolio, providing scientific and strategic leadership for early- and late-stage studies (asthma and/or COPD).
- Drive development and execution of clinical development plans (CDPs), target product profiles (TPPs), and end-to-end risk–benefit assessments.
- Design and develop clinical trial protocols and associated documents in collaboration with clinical development and operations leaders.
- Lead development of study plans, data review plans, and the clinical components of regulatory submissions (IBs, CSRs, briefing books, BLAs, MAAs).
- Partner with Biostatistics, Data Management, and Safety colleagues to ensure scientific rigor and regulatory compliance.
- Interpret clinical data and provide strategic insights to support decision-making and lifecycle planning.
- Guide oversight of data monitoring committees (DSMB, Endpoint Adjudication Committee) for late-stage studies.
- Provide strategic input into publication strategy and ensure timely delivery of abstracts, manuscripts, and presentations.
- Act as a senior representative with external stakeholders, including investigators, KOLs, CROs, and regulators.
- Lead, mentor, and develop a team of clinical scientists, fostering a high-performance, inclusive culture.
Requirements
- Advanced degree (PhD, PharmD, MD, or equivalent) required.
- 12+ years of industry experience in clinical development, with significant end-to-end experience in respiratory (asthma and/or COPD) programs.
- Demonstrated success in both early- and late-stage clinical trials, including regulatory submissions (BLA, MAA).
- Deep knowledge of clinical research methodologies, GCP, and global regulatory requirements.
- Strong analytical, communication, and leadership skills with the ability to influence across functions and levels.
- Track record of successfully leading clinical strategy, execution, and regulatory engagement for pivotal trials.
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development plansclinical trial protocolsregulatory submissionsdata monitoring committeesclinical research methodologiesGCPanalytical skillsstrategic insightsrisk-benefit assessmentspublication strategy
Soft skills
leadershipcommunicationmentoringinfluencingteam developmentstrategic inputcollaborationhigh-performance cultureinterpersonal skillsproblem-solving
Certifications
PhDPharmDMD
