Director, Drug Safety

Boston, MA

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

DIRECTOR, DRUG SAFETY

We’re looking for a Drug Safety Director to join the Pharmacovigilance team and report to the Vice President, Pharmacovigilance and Drug Safety.

A successful candidate in this role is an experienced MD in Drug Safety that will provide ongoing medical evaluation/review of cases (ICSR), assisting in DSUR creation, protocol development, and will be responsible for managing/overseeing all safety issues and regulatory requirement/submissions for one or more molecule in development. The candidate for Drug Safety will be responsible for interacting/overseeing CROs/vendor sites and process improvements. The candidate will also be responsible for ensuring safety data quality and implementing risk management/mitigation strategies.

This will require the candidate to be onsite and attend all the clinical study team meetings and also inform and present ongoing safety issues to the team. The candidate will also serve as an expert on safety issues to the rest of the team. Strong communication verbal and written presentation skills are important in this highly visible role.

ESSENTIAL JOB FUNCTIONS:

  • Heavily integrated into the ICSR workflow to provide Medical Review. Medical review will include verifying accuracy of previously entered assessments, creating a Company comment, and analysis of Similar Events.
  • Prepare/review safety aggregate data reports (DSURs) and maintain data integrity.
  • Assist/author the clinical study protocols, IBs, ICFs, DSUR, and other relevant safety sections, 6-month line listings, internal safety assessment reports.
  • Ensure safety data quality and data integrity.
  • Leads Investigator Brochure development for safety sections including Reference Safety Information.
  • Contribute to IND/NDA submissions and Risk Management Plans.
  • Develop materials and conduct training sessions when appropriate to a variety of audiences.
  • Participate in cross-functional monitoring of the study data with Medical Monitors and VP of Pharmacovigilance and Drug Safety.
  • Ability to assign priority within a clinical development environment at all phases of multiple programs.

JOB REQUIREMENTS:

  • MD or equivalent medical training. Should have at least 2 years of clinical experience, and at least 5 years of experience in Drug Safety/Pharmacovigilance.
  • Expert knowledge of FDA CFR, ICH and clinical development programs is required. Preferably working knowledge of EMA GVP and CIOMS.
  • Drug safety surveillance experience in oncology/hematology preferred.
  • Ability to interpret related regulatory guidance and problem solve towards a compliance approach with a background and understanding of industry best practices.
  • Working knowledge of MedDRA coding and its appropriate use in data mining.
  • Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives.
  • Medical writing experience required.
  • Ability to prepare Powerpoint safety presentations.
  • Ability to work efficiently and effectively with minimal supervision.
  • Excellent collaboration and communication skills are required.

THE KURA PACKAGE

  • Career advancement/ development opportunities
  • Competitive comp package
  • Bonus
  • 401K + Employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • Generous Benefits Package with a variety of plans available with a substantial employer match
  • Paid Paternity/Maternity Leave
  • In-Office Catered lunches
  • Home Office Setup
  • Cell Phone and Wellness Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. To apply, please submit your resume to careers@kuraoncology.com