Clinical Development Scientist/Senior Clinical Development Scientist Tenvie Therapeutics is developing precision-engineered small molecule therapies to address core drivers of neurological and ...
Clinical Development Scientist/Senior Clinical Development Scientist Tenvie Therapeutics is developing precision-engineered small molecule therapies to address core drivers of neurological and ...
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POSITION SUMMARY The Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in ...
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POSITION SUMMARY The Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in ...
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Quick apply
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About the Role The Clinical Development Scientist will support the design, execution, and interpretation of clinical studies for oncology-focused in vitro diagnostic products. The scientist will be ...
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The Vice President, Clinical Development will initially serve as a highly hands-on individual contributor responsible for advancing ongoing and planned clinical programs, with a particular focus on ...
The Vice President, Clinical Development will initially serve as a highly hands-on individual contributor responsible for advancing ongoing and planned clinical programs, with a particular focus on ...
The Vice President, Clinical Development will initially serve as a highly hands-on individual contributor responsible for advancing ongoing and planned clinical programs, with a particular focus on ...
Quick apply
The Vice President, Clinical Development will initially serve as a highly hands-on individual contributor responsible for advancing ongoing and planned clinical programs, with a particular focus on ...
Sr. Director, Clinical Development
$84K - $115K/yr
Responsible for leading development and execution on strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers ...
Sr. Director, Clinical Development
$84K - $115K/yr
Responsible for leading development and execution on strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers ...
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How much do clinical development jobs pay per hour?
What is the difference between Clinical Development vs Clinical Research Coordinator?
| Aspect | Clinical Development | Clinical Research Coordinator |
|---|---|---|
| Required Credentials | Bachelor's degree, often advanced degrees in life sciences or related fields; certifications like CCRP or RAC | Bachelor's degree in health sciences or related field; certifications like CCRP beneficial |
| Work Environment | Pharmaceutical or biotech companies, clinical trial teams, R&D departments | Clinical trial sites, hospitals, research centers |
| Employer & Industry Usage | Used in pharmaceutical, biotech, and medical device industries during drug development phases | Used in hospitals, research institutions, and clinical trial sites for managing patient studies |
While both roles are involved in clinical trials, Clinical Development focuses on designing and managing the overall drug development process, whereas Clinical Research Coordinators handle the day-to-day operations at trial sites, ensuring protocol adherence and patient coordination.
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Clinical Development Scientist/Senior Clinical Development Scientist
Brisbane, CA • On-site
Full-time
Posted yesterday
Job description
Tenvie Therapeutics is developing precision-engineered small molecule therapies to address core drivers of neurological and peripheral diseases: neuroinflammation and cellular dysfunction. Leveraging its proprietary product engine, Tenvie has the unique ability to advance both fully CNS-penetrant and peripherally restricted products across a broad portfolio. Tenvie's most advanced programs, TNV262 and TNV108, are in Phase 1 clinical development. TNV262 is a fully CNS-penetrant NLRP3 inhibitor targeting cardiometabolic and neuroinflammatory indications, including obesity and cardiovascular disease, and multiple sclerosis. TNV108 is a peripherally restricted SARM1 allosteric inhibitor targeting peripheral neuropathies. Tenvie's clinical pipeline is complemented by discovery-stage programs across a range of related indications.
Tenvie Therapeutics is seeking a scientifically rigorous and highly collaborative Clinical Scientist to support the design and execution of early clinical development programs in cardiometabolic disease and related indications. This role is ideal for candidates with a strong background in human pathophysiology and clinical trial design who are motivated to translate biology into impactful therapies. The Clinical Scientist will work closely with Clinical Development, Clinical Operations, Biometrics, Translational Science, and Regulatory to ensure high-quality clinical plans, protocols, and data readouts. This role can be remote, hybrid, or on-site, and reports within the Clinical Development group.
JOB RESPONSIBILITIES:
- Contribute to clinical strategy and study design
- Support development of clinical development plans, target product profiles, and indication prioritization
- Lead or co-lead the scientific design of Phase 1-2 studies (e.g., FIH, dose-finding, PoC) including objectives, endpoints, inclusion/exclusion criteria, and biomarker strategy, with emphasis on cardiometabolic risk factors and outcomes
- Integrate nonclinical, translational, and clinical data to inform dose selection, schedule, and patient population
- Lead development of core clinical documents
- Author or co-author clinical sections of protocols, protocol amendments, IBs, ICFs, CSRs, and relevant regulatory documents (e.g., briefing books, responses to health authority questions)
- Develop and maintain study-level documents including synopsis, statistical analysis-relevant endpoint definitions, and data review plans
- Partner with Biostatistics and Clinical Pharmacology on endpoint hierarchy, PK/PD modeling plans, and interim analyses
- Drive study conduct and data quality
- Serve as Clinical Scientist lead on cross-functional study teams for selected trials
- Provide clinical and scientific input into site selection, eligibility adjudication, and key study tools (e.g., manuals, training decks, CRFs)
- Participate in ongoing medical and scientific data review (safety, PK/PD, biomarkers, efficacy signals); help define and track key data review listings and visualizations
- Support development and execution of safety review / dose escalation committees and data monitoring activities
- Lead data interpretation and communication
- Lead or co-lead integrated analyses of clinical, PK/PD, and biomarker data to generate clear conclusions and next-step recommendations
- Prepare data summaries and presentations for internal governance, external collaborators, and advisory boards
- Contribute to abstracts, posters, and manuscripts for scientific meetings and peer-reviewed journals
- Interface with investigators and external partners
- Provide scientific support to investigators and study sites (e.g., training, protocol clarification, scientific Q&A)
- Participate in KOL and expert advisory boards, contributing to agenda, content, and follow-up
- Collaborate with CROs, central labs, imaging/biomarker vendors, and other partners to ensure alignment on scientific and operational expectations
- Contribute to portfolio and organizational excellence
- Support cross-program learnings and standardization of endpoints, assessments, and data structures across cardiometabolic and related indications
- Help refine internal processes and templates for protocols, charters, and data review
- Mentor junior team members as appropriate; model a high-accountability, low-ego, cross-functional working style
QUALIFICATIONS:
- Education
- PhD in life sciences, pharmacology, physiology, or related field strongly preferred; MD, PharmD, or equivalent clinical degree also considered
- Strong foundation in cardiometabolic biology (e.g., obesity, insulin resistance, dyslipidemia, NAFLD/NASH, cardiovascular risk) is highly preferred
- Experience
- Typically 3-7+ years of relevant experience in clinical development, clinical pharmacology, or translational medicine within biotech/pharma or equivalent academic clinical research environment
- Demonstrated experience contributing to design and execution of early-phase (Phase 1-2) clinical trials
- Cardiometabolic and/or obesity clinical trial experience preferred, including familiarity with standard endpoints (e.g., glycemic control, body weight, lipids, blood pressure, imaging or functional assessments)
- Experience working on cross-functional teams with Clinical Operations, Biometrics, Regulatory, and Translational/Discovery
- Prior involvement in regulatory submissions (e.g., IND/CTA, briefing packages, responses to queries) is a plus
- Technical skills
- Strong understanding of clinical trial methodology, GCP, and the overall drug development pathway from FIH through proof-of-concept
- Comfort interpreting PK/PD, biomarker, and clinical efficacy/safety data, and working with statisticians and pharmacometricians
- Experience with cardiometabolic risk scoring, metabolic biomarker panels, or imaging modalities is an advantage
- Excellent scientific writing skills with a track record of clear, structured documents and presentations
- Core competencies
- Highly organized, with the ability to manage multiple studies or workstreams in parallel in a fast-paced environment
- Strong analytical and critical-thinking skills; able to move from complex data to clear, actionable recommendations
- Effective communicator, able to tailor scientific messages to diverse audiences (clinicians, scientists, operations, leadership, regulators)
- Demonstrated ability to work collaboratively and constructively across disciplines and with external partners
- Comfortable operating with ambiguity and evolving data; proactive in identifying risks and proposing solutions
- Commitment to high ethical standards, patient safety, and data integrity
Expected salary range:
- $125,000-180,000 annual base salary
Tenvie is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.