Sr. Clinical Scientist / Associate Director (Contractor)

Reports To: VP, Clinical Science

Department: Clinical Science

Location: South San Francisco / Hybrid / Remote

 

ABOUT THE JOB

We are seeking a Senior Clinical Scientist / AD Clinical Scientist (Contractor) to join the Clinical Science team.  This individual will be responsible for supporting or leading 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).

 

This position will also have the opportunity to take on the role of Medical Monitor for at least one study, based on their capabilities and clinical experience/expertise.

 

The ideal candidate is someone who has a strong scientific background, thinks innovatively, is detailed-oriented and works effectively in small and motivated teams, has a passion to bring potentially transformative therapies to patients, and thrives when supported by mentors and colleagues to take ownership of their contributions to both the molecule and Clinical Science teams.

 

OUR CORE VALUES

The below core values drive all that we do here at Star.  We are looking for like-minded individuals that feel passionately about these same values to join our team.

  • Patients Are Our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
  • Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
  • Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

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 scientific 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
  • Perform clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety, data quality, and appropriate interpretation for assigned study/studies.
  • Lead and participate in operational excellence projects and audit readiness activities, as appropriate
  • Initiate and provide 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
  • 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 functional leadership 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
  • Assist with content development and attend and present at Investigator Meetings and other internal and external stakeholder meetings, as needed
  • Present study updates and topline results to Clinical Development leadership, as needed
  • Performs other related duties as assigned

 

EDUCATION, EXPERIENCE & QUALIFICATIONS

  • Advanced science/health degree, such as PhD, PharmD, MSN
  • At the Sr Clinical Scientist level – the position requires at least 5 years of experience within Clinical Science, preferably in late-stage clinical development programs. At the AD, Clinical Scientist level, the position requires 6-8 years of experience, preferably in late-stage clinical development programs.
  • Ability to navigate EDC and laboratory database systems to review data
  • Proficient in clinical research regulatory requirements (e.g., GCP and ICH)
  • Prior successful IND/CTA and/or NDA/BLA/MAA submission preferred. Experience supporting and participating in regulatory inspections desired.
  • Proficient with Microsoft Word, Excel, and PowerPoint
  • Ability to write clearly and concisely
  • Ability to present with clarity and compellingly
  • Detail-oriented
  • 20% - 25% travel required

 

ABOUT STAR THERAPEUTICS

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors.  We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Star is headquartered in South San Francisco, CA.  Star offers competitive pay, and we take pride on being an awesome place to work.  More information about Star can be found on our website at www.star-therapeutics.com.

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

We anticipate the hourly rate for the Sr Clinical Scientist (Contractor) position in our South San Francisco, CA office to range from $90 to $110 per hour and the Associate Director Clinical Science (Contractor) to range from $100 to $130 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location.  The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

This is an in-office / hybrid / remote position. Qualified candidates should apply via our careers page at: https://star-therapeutics.com/our-careers/  NO PHONE CALLS or AGENCIES, please.