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Safety Scientist Lead

Orca Bio

Orca Bio

Remote
Posted on Wednesday, December 6, 2023
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
The Safety Scientist position will mark our first hire in the field of patient safety and risk management. The incumbent will have the opportunity to take on a leadership role, offering excellent prospects for career advancement.

Responsibilities:

  • Lead risk management and mitigation activities for assigned products.
  • Co-lead pharmacovigilance activities for regulatory filings.
  • Represent Orca’s pharmacovigilance organization at regulatory inspections.
  • Stay abreast of changes in regulations, leading updates to SOPs and process documentation.
  • Identify and address process gaps, contribute to oversight of vendor relationships and training budgets.
  • Oversee project distribution across therapeutic areas and represent product safety in program teams.
  • Participate in safety data review and analysis for products in designated areas.
  • Lead Signal Review Meeting and Signal Management Team activities in collaboration with Medical Directors.
  • Lead safety related activities for regulatory filings including aggregate safety data reporting, signal detection and risk identification, ICF review, CSR review, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.

Qualifications:

  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
  • 5-7 years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO company.
  • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
  • Experience with Risk Management and Minimization programs.
  • Proficiency in preparing pre-marketing (eg, investigational) and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
  • Experience with clinical development, risk/benefit analysis, and safety assessment.
  • Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
  • Prior experience working on BLA/NDA. Prior experience leading risk management activities for BLA/NDA preferred.
  • Hands-on mentality, ability to operate with limited resources.

Highly Desired:

  • Knowledge of cell therapy or hematology oncology is a plus.
  • Expertise with analysis of safety data from clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Excellent independent judgment based on knowledge and expertise.
  • Strong personal time management and project management skills.

Additional Information:

  • Minimal travel required; can be based anywhere.
  • Estimated start date Q1/Q2 of 2024.
The anticipated salary range for this U.S. based job is TBD. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.