Job Description

Overview

Remote - United States

VICE PRESIDENT, PHARMACOVIGILANCE AND PATIENT SAFETY

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from day one to the future theyve envisioned.

POSITION SUMMARY

The Vice President, Pharmacovigilance and Patient Safety will join as a pivotal member of the Research and Development senior leadership team and play a significant role in managing the multiple facets of drug safety and pharmacovigilance focused on product development as the Company continues to scale and grow. This individual will report to the Chief Medical Officer (CMO) and will work in close collaboration with the Head of Research and Development (R&D).

The Vice President, Pharmacovigilance and Patient Safety will provide leadership to the Pharmacovigilance and Patient Safety (PPS) Team, working cross-functionally as well as with external functions and regulatory authorities, to lead and direct the oversight of clinical safety, risk management, and compliance with pre- and post-marketing regulations. This includes assuring compliance of all clinical studies in accordance with domestic and international requirements for drug safety oversight and reporting through late-stage development, licensure, and commercialization in the U.S., Europe, and other regions. This position will have a high degree of visibility and impact across the organization and will collaborate closely with other executive team members to provide equivalent support to the Pharmacovigilance/Safety Surveillance and to the Clinical Development/Regulatory/Operations/Systems/QMS groups.

Day One Bio is preparing and planning for significant growth and the Vice President will possess the strategic and people skills to work effectively in a dynamic, cross-functional, growing organization. This role will assume leadership of a strong existing team of safety operations and medical personnel and oversee pharmacovigilance activities at the operational, product, enterprise and external alliance management levels.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

Responsibilities

• Serve as the subject matter expert (SME) on global drug safety requirements in all phases of drug development and post-market support, providing leadership in the transition from a clinical stage company into an organization encompassing global post-market drug safety and risk management.
• Represent the Pharmacovigilance and Patient Safety Department across all Day One Bio programs.
• Lead and oversee the fundamental activities of Safety Operations including continuous safety data collection and compliant regulatory reporting.
• Lead and oversee Pharmacovigilance signal detection, risk management activities and risk mitigation strategies throughout the lifecycle of Day One Bios products.
• Provide oversight and management of pharmacovigilance agreements (PVAs) and relationship management with Development Partners.

• Ensure ongoing evaluation of the overall safety profile for all of Day One Bio's investigational products and regular presentation of safety data in cross-departmental safety review meetings.
• Identify matters that need escalation to senior leadership via internal safety governance processes.
• In coordination with Regulatory Affairs, plan and support safety input into regulatory submissions including registration product applications and product labeling for the safety sections of the assigned products and indications (e.g., CCSI, USPI).
• Represent the company at Safety meetings and lead responses to and/or resolution of regulatory safety enquiries from regulatory agencies and health authorities.
• Serve as Standing member and Deputy Chair of the Safety Review Board for Safety Governance.
• Member of the Senior Leadership Team (SLT).

• Provide drug safety expertise and review for the accuracy and quality of all safety sections in pre- and post-approval documents with timely communication of recommendations and/or actions to internal and external stakeholders.
• Support Clinical Development, Clinical Operations, and Medical Affairs teams with respect to safety-related issues as required.
• Participate in planning, review and approval of clinical trial safety documents and aggregate safety reports (e.g., DSURs, PADERs) including content of clinical protocols and Investigators Brochures, annual reports, final study reports and other documents as needed.
• Provide input and review of responses to regulatory agency questions with regard to safety and pharmacovigilance activities.

• Assess global PV requirements for resources, equipment, and systems to maximize efficiency.
• Ensure thorough collection and reporting of existing safety data from all sources to characterize risk over time and maintain a positive benefit-risk balance.
• Develop overall risk management plans, pharmacovigilance strategies, and risk minimization activities.
• Ensure robust integrity and maintenance of a global safety database to ensure compliance of the safety system for approved products and products in the portfolio.
• Lead optimization of the current signal detection system to ensure signal identification, evaluation, and validation through product lifecycle and with consideration for global partnership PVAs.
• Represent Global Drug Safety at regulatory authority meetings and at external conferences and conventions.

• Lead cross-functional and cross-departmental interactions with clinical development, medical affairs, regulatory affairs, and commercial groups.
• Collaborate with the business development team to contribute to due diligence activities.
• Interact and represent safety and pharmacovigilance purposes, representing the Company with selected Corporate Partners.
• Hire, develop, and mentor the Pharmacovigilance and Patient Safety team.
• Assess and align the organization to meet the goals of the long-range business plan.

Qualifications

• M.D. or D.O. degree required with 15+ years experience in a Drug Safety/PV Department in a pharmaceutical/biotech company.
• Therapeutic experience in pediatric medicine, pediatric oncology or adult hematological-oncology, or related therapeutic experience is highly desirable.
• Entrepreneurial, small/high growth company experience preferred.
• Experience leading a multifaceted team of safety physicians, safety systems, and operations personnel and the ability to reevaluate team needs and resources in an evolving company.
• Strong track record of supporting regulatory (IND, NDA/BLA, MAA) and product launch success that entails developing drug safety and PV processes to support the transition of product development into product approval/post-market.
• Solid knowledge of current and emerging regulatory requirements and expectations including GCP, FDA, and EU GVP regulations and international guidelines.
• Extensive Pharmacovigilance management experience in early (First in Human) to late-stage clinical settings, including oversight of 3rd party drug safety activities, internal pharmacovigilance review processes and drug safety assessments, safety signal detection and identification, reporting procedures, compliance, and risk management.
• Proven Safety lead for US and OUS health authority interactions including pre-NDA/MAA IRs and meetings, review cycle requests, ODAC meetings, and post-marketing requirements.
• Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
• Excellent interpersonal skills, ability to develop strong relationships with key stakeholders, skillful conflict management and negotiation skills, ability to identify issues early and develop relevant and realistic plans, programs and/or recommendations.
• Strong and clear communicator, both orally and in writing.
• Embrace Day One Bios core values and enthusiastically join the mission, inspiring others.
• Kindness, patience, humor, and compassion are all desirable assets to possess and to share with others.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

Compensation and Benefits

The salary range for this position is $370,000 $395,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticals internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.

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