Position Summary

Reporting to the VP, Clinical Development, the Medical Director is responsible for leading and supporting tasks related to Clinical Science deliverables across the various stages of clinical development—study design and execution, data analysis, and regulatory filings—in accordance with program needs.  These include drafting key documents to support study conduct; reviewing and interpreting clinical data; and leveraging relationships with external parties (KOLs/Investigators).

 

The Medical Director will also be expected to take on the role of Medical Monitor for at least one study.  The right candidate is someone who has a strong clinical and scientific background, thinks innovatively, works effectively in small and motivated teams, has a track record of proactively overseeing trials as the primary medical monitor, has a passion to bring potentially transformative therapies to patients, and thrives when supported by mentors to take ownership of their contributions to both the molecule and Clinical Science teams and if/when supporting the work of junior colleagues.

 

Primary Responsibilities

  • Develop and/or contribute to key documents to support the components of trial execution and regulatory submissions (e.g., IND Annual Reports, Investigator Brochures, Briefing Books, and Pediatric Plans)
  • Develop scientific rationale for methods, design, and implementation of clinical protocols, data collection systems, and final reports
  • Act as the clinical subject matter expert and primary contact for the assigned clinical study; take a proactive approach to identifying issues and mitigating risk
  • Conduct periodic review of protocol deviations in collaboration with the Clinical Operations Study Lead or designee
  • Initiate and provide the clinical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions; and other key study deliverables
  • Conduct review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate interpretation, following thorough review of SAEs and other important AEs (per the study-specific Medical Monitoring Plan)
  • Contribute to and review Clinical Study Report (CSR) writing (review final tables, listings, and figures; work with medical writer to review & revise CSR document; draft discussion and conclusions; and participate in comment resolution meetings)
  • Support the design, update, and implementation of Clinical Development Plans (CDPs) and work with Project Management to ensure progress is in line with current plans and timelines
  • Collaborate with translational research on biomarker selection and data interpretation, design of non-clinical experiments, and analysis of subject samples to support clinical efficacy and safety evaluation
  • Stay up to date with advances in the rare blood disorders literature, including mechanism of action, diagnostic tests, standard of care treatments, drug development trends, and regulatory requirements
  • Attend and present at Investigator Meetings, as needed
  • Present study updates and topline results to the internal and external audiences, as needed

 

Requirements

  • Ability to navigate EDC and laboratory database systems to review data
  • Proficient with Microsoft Word, Excel, and PowerPoint
  • Ability to write clearly and concisely
  • Ability to present with clarity and compellingly

 

Education & Professional Experience:

  • Medical Degree or equivalent
  • At least 3 years of clinical experience, preferably caring for patients with bleeding disorders
  • At least 3 years of industry experience within Clinical Science, preferably in both early- and late-stage clinical development programs
  • Prior successful IND/CTA and/or NDA/BLA/MAA submission preferred


Salary Range

  • The hiring salary range for candidates residing in California for this position is $244,000 - $285,000 annually.  This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

 

*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.