Safety Director Jobs

About The Position

Requirements

• PhD in a relevant field, DVM, MD, or equivalent degree.
• At least 8 years of demonstrated pharmaceutical industry experience as a nonclinical safety scientist (such as in toxicology or pathology) and/or as a nonclinical safety assessment representative on cross-functional development or discovery teams.
• Demonstrated ability to navigate cross-functional lines and drive team decision-making in a matrix organizational structure.
• Ability to solve problems creatively and deliver goals and objectives in a timely manner.
• Collaborative team player able to work with discovery team members from various functions, other DPLs, and scientists responsible for study conduct and portfolio management.
• Strong interpersonal skills and ability to establish effective working relationships with employees at all levels.
• Excellent communication skills, including judgment about when and how to speak up and raise issues to stakeholders and management.
• Required skills listed: Clinical Safety, Finite Element Analysis (FEA), Good Lab Practices, Immuno-Oncology, Innovative Thinking, Matrix Management, Quality by Design, Regulatory Filings, Regulatory Submissions, Safety Management, Strategic Thinking, Technology Transfer, and Toxicology.

Nice To Haves

• Experience with biopharmaceutical and small-molecule pharmaceutical development and/or discovery.
• Experience with regulatory submissions and responses.
• Membership in pharmaceutical consortia and/or external scientific or professional organizations.

Responsibilities

• Represent Nonclinical Drug Safety on discovery teams and participate in therapeutic-area discovery governance committee reviews.
• Promote and facilitate creative thinking from target identification and validation through lead optimization across Infectious Disease, Neuroscience, Immunology, Oncology, and/or Cardiometabolic therapeutic areas.
• Influence cross-site disease-area groups and functional disciplines to promote innovative drug discovery.
• Identify and assess potential risks associated with therapeutic targets or development candidates using literature, internal data, and external information.
• Define and oversee NDS strategy across modalities from target identification through approval of first-in-human-enabling GLP toxicity studies.
• Develop de-risking strategies for discovery programs and collaborate with NDS staff at other sites to execute appropriate studies.
• Support selection of therapeutic targets and identification and development of drug candidates.
• Potentially lead early development teams and inform preclinical studies supporting product development.
• Potentially define GLP toxicology study strategy and execution on development teams.
• Potentially prepare or contribute to nonclinical safety sections of regulatory documents supporting clinical trials and worldwide marketing authorization.
• Navigate cross-functional teams and drive team decision-making in a matrix organization.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.