Sr. Clinical Trial Lead

South San Francisco, CA
Full Time
Experienced
Who we are
At Abdera Therapeutics, we are on a mission to revolutionize cancer treatment. Leveraging our proprietary ROVEr™ platform, we engineer precision radiotherapeutics that finely tune radioisotope delivery to maximize therapeutic effects while sparing healthy tissue. Our innovative approach holds the potential to transform the treatment of a broad range of solid tumors. Abdera’s lead program, ABD-147, is a next-generation precision radiopharmaceutical biologic therapy in Phase 1 clinical development and is designed to deliver Actinium-225 (225Ac) to solid tumors expressing delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC).
Our company, technology, and team are purpose-built to attack cancer head-on. Led by a dynamic team of scientists and industry veterans with extensive experience in oncology, radiopharmaceuticals, and biologics, we are united by a shared passion for cutting-edge science and a relentless pursuit of optimized therapies for people living with cancer.
What we look for
At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We believe in the power of collaboration and innovation. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies.

Job Location: South San Francisco, CA
Salary range:
135k – 170k
Job Summary
The Sr Clinical Trial Leader (Sr CTL) will report to the Head of Clinical Operations and work closely with the Clinical Development Lead dedicated to the program. The Sr CTL will be responsible for managing the overall clinical operational activities for a given clinical study. The Sr CTL will be responsible for CRO and CSP selection and oversight, as well as cross functionally within Abdera, to ensure quality conduct of trials and collection of data.

The Sr CTL must be able to work effectively with functional peers (e.g., Project Management, Clinical Development, Regulatory Affairs, CMC/Supply Chain, etc.) within a project team environment.
 
Principal Responsibilities
  • Responsible and primary point of contact for the operational leadership and
  • strategy of the assigned study/studies
  • Provide functional expertise for the Clin Ops strategy and tactical implementation of the study/studies by managing timelines, deliverables, operational team, budget forecasting and management, and CRO/CSP oversight
  • Oversight of the operational aspects for the development and delivery of study protocols, informed consents, CRO/CSP selection/management, site/countryselection, data monitoring/data collection, study plans, quality initiatives, data review, Inspection Readiness
  • Manage and drive content, agenda, and discussions at clinical operations related cross-functional meetings and ensure action items are closed
  • Develop and execute study-specific risk management plans (e.g., milestones,metrics, critical path) ensuring appropriate escalation when required
  • Evaluate study-level issues for broader impact (e.g., cross-study, cross-
  • Program etc.) in a timely fashion and ensure resolution
  • Use judgement to proactively identify and remediate study issues (able to make recommendations/decisions swiftly and independently and include/communicate to appropriate stakeholders)
  • Line management responsibilities, which includes hiring talent, providing guidance, performance development, coaching and mentoring
  • Ensure effective study communications to internal and external stakeholders through meetings, presentations, and other methods
  • Provide Clinical Operations Leadership with timely updates on progress and changes in scope, schedule, and resources across the program
  • Participate in resource prioritization to ensure clinical operations strategic goals and milestones are achieved  
  • Participate in assessment and recruitment of new Clinical Operations team members  
  • Work closely with other functions to ensure GXP compliance · Develop and maintain professional relationships with key opinion leaders
  • Represent the company at meetings with external attendees
Qualifications, Education & Experience
  • Bachelors/master’s degree (or equivalent) in a health care of other scientifically
  • related field
  • 7+ years of related industry experience as a CRA/Trial Manager or related
  • function with increasing responsibility and scope
  • Previous experience in the management/conduct of regional early
  • development and global late phase oncology clinical trials
  •  Radiopharmaceutical expertise a definite plus
  • Regulatory inspection experience a plus
  • Strong knowledge of ICH/GCP guidelines for US/global compliance
  • Previous supervisory experience
Skills and Abilities
  • Skills and Abilities
  • Leadership skills critical; demonstrates vision and commitment
  • Demonstrated ability to influence and lead others to deliver quality results in a timely manner in both independent and team environments
  • Effective communication skills; verbal, written, and presentation
  • Strong organizational skills and the ability to prioritize and multi-task
  • Positive, highly motivated, able to multi-task, enjoys working in a fast-pacedenvironment and thrives under pressure
  • Flexible as it relates to responsibilities/assignments; job scope/role may evolveas the company grows and matures
  • Must think strategically and drive decisions/study forward with the ability to weigh both the short- and long-term impact of decisions
  • Capable and enthusiastic about managing and mentoring junior Clin Ops employees
  • Financial acumen in creating and managing large clinical program budgets
  • Excellent judgment and critical thinking skills
  • Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook) and extensive experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.)


Abdera is committed to the well-being of their employees.  Our comprehensive benefits package includes Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D Insurance, both Short-term and Long-term disability;16 paid company holidays; 20 days of PTO and 6 sick days;401k with up to 3.5% company match, equity, and bonus.   We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities. 

Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.
 
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Human Check*