Medical Director, Pharmacovigilance and Patient Safety

MEDICAL DIRECTOR, PHARMACOVIGILANCE AND PATIENT SAFETY                         

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

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 POSITION SUMMARY:

We are looking for a highly skilled Medical Director with expertise in safety data management, safety databases, and periodic report authoring, as well as experience in managing safety signals. The successful candidate will provide medical leadership and oversight to ensure the accurate and efficient analysis of safety data, identification of potential safety signals, and compliance with regulatory requirements.

This position reports to the Vice President, Pharmacovigilance and Patient Safety and has the potential to be fully remote. Travel of 10%-15% will be typically required for in-person meetings and conferences.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·       Provides medical expertise in the analysis of safety data from clinical trials and post-marketing sources

·       Participates in the medical review of case narratives for medical content, accuracy, and signal detection

·       Helps oversee the management of safety databases (e.g., Argus, Rx Logic) and ensure accurate and timely entry of safety data

·       Participates in data analysis and serves as a co-author for periodic reports (e.g., DSURs, PSURs, etc) and other regulatory documents related to safety

·       Identify and manage potential safety signals, including evaluation and risk assessment and participates in benefit-risk analysis for all assigned compounds

·       Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Safety Operations

·       Ensures compliance with global regulatory requirements and company procedures for pharmacovigilance

·       Participates in the analysis of the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict/establish the safety profile of compounds in clinical development

·       Provides medical input on safety-related issues and contribute to the development of safety strategies

·       May participate in safety data to Data Monitoring Committees or assigned products and internal Safety Assessment Committees

·       Participates in cross-functional project teams including Clinical Trial Study Teams; communicates across organizational levels and functions

·       Participates in SOP updates, audits, and inspection readiness

·       Participates in authoring/updates of core safety information for assigned projects in collaboration with Safety Operations

·       Supports preparation for external meetings with Health Authorities

·       May participate in guidance and/or training of external personnel/parties involved in Company's clinical studies where applicable to Medical Safety

·       Collaborates effectively in cross-functional and cross-cultural project teams and works with external providers

·       Maintain clinical and technical expertise in the therapeutic areas, i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.

·       May participate/present safety material to Company and Investigator's meetings and other medical meetings

·       Willing to participate in workshops and trainings to build skills and knowledge of drug development in pediatric and rare disease

·       Oversight of contract team members and projects as necessary

QUALIFICATIONS

·       Medical Degree (e.g., MD, MBBS, DO) required

·       5+ years' experience as an Industry Medical Safety Physician or similar experience with safety oversight activities related to industry clinical trials via a CRO or academic center running industry trials

·       Foundational knowledge of clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities, including regulations governing pharmacovigilance

·       Strong skills in the management of safety information originating from both clinical development and post-marketing sources

·       Excellent knowledge of industry standard pharmacovigilance databases, particularly Argus and Rx Logic

·       Strong leadership skills and ability to communicate with individuals at all levels

·       Excellent oral and written communication skills

·       Excellent analytical skills, detail-oriented, and ability to work independently

·       Ability to exercise creativity and judgment

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

COMPENSATION AND BENEFITS

The salary range for this position is $250,000 - $265,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One 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 Biopharmaceutical’s 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.