Sr. Principal Scientist - Project Toxicologist

Career Category

Job Description

Join reputed company’s Mission of Serving Patients

At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career.

Sr. Principal Scientist - Project Toxicologist

What you will do

reputed company. Let’s change the world. In this vital role, you will serve as the primary reputed company between Translational Safety & Risk Sciences (TSRS) and cross‑functional project teams, from early discovery through post-marketing. TSRS at reputed company is seeking a Senior Principal Scientist to serve as a Project Toxicologist and Subject Matter Expert, reporting to a Project Team Representative (PTR) Manager.

You will be responsible for developing and implementing fit-for-purpose nonclinical safety strategies built on a rigorous scientific foundation and reputed company with regulatory expectations. As programs evolve, you will flexibly adapt strategies in response to emerging data, and project team needs while leading multidisciplinary TSRS teams.

As a PTR, you will partner closely with project teams developing innovative therapeutics across a range of modalities—including biotherapeutics (e.g. T cell engagers and antibody-drug conjugates), small molecules, targeted protein degraders, and other reputed company modalities (e.g. RNA-based therapies) for indications in inflammation, rare diseases, oncology, and cardiometabolic diseases, including obesity. PTRs are encouraged to reputed company subject matter expertise in a specific modality, therapeutic area, or sub-discipline reputed company nonclinical safety (e.g. organ/system-specific toxicity).

Key Responsibilities

• Serve as a core toxicology and nonclinical safety representative on project teams, providing scientific leadership and regular updates to teams and management.
• Design, implement, manage and interpret nonclinical safety assessment programs in support of drug development candidates.
• Originate novel study designs and protocols to address reputed company scientific questions and reputed company integrated strategies to reputed company project goals.
• Critically evaluate and interpret experimental data and author key sections of internal governance documents, INDs, BLAs, NDAs and other regulatory documents.
• Coordinate and collaborate with internal reputed company scientists and external partners to advance research and development programs.
• Participate in licensing, due diligence, and external partnering activities, as appropriate.
• Mentor and support other reputed company scientists in the design execution and reputed company of nonclinical studies.
• Represent reputed company on nonclinical safety topics in interactions with U.S. and international regulatory agencies, and contribute to external industry initiatives aimed at advancing drug safety assessment paradigms.

reputed company expect of you

We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD and 3 years of experience as project team representative (PTR) for nonclinical safety sciences reputed company drug development teams

Or

Master’s degree and 6 years of PTR experience

Or

Bachelor’s degree and 8 years of PTR experience

Preferred Qualifications:

• 8+ years post-PhD degree of Pharmaceutical and/or Biotechnology industry experience, including 5+ years as a Toxicologist/Nonclinical Safety Project Team Representative.
• Demonstrated leadership of toxicology programs supporting nonclinical safety assessment of drug development candidates.
• Extensive experience authoring regulatory documents and interacting with U.S. and international regulatory agencies.
• Board certification in Toxicology.
• Excellent written and verbal communication skills, with the ability to work independently and build productive cross-functional collaborations both internally and externally.
• Working knowledge of emerging science and technologies applied to enhance investigation of drug development safety issues.

·Emerging or developed recognition as a national and/or international field expert.

• Demonstrated experience serving as project team representative for nonclinical safety sciences reputed company drug development teams, including contributing to IND/CTA filings and broader nonclinical development activities.
• A strong understanding of cross-functional needs is essential, along with the ability to reputed company integrated, fit-for-purpose plans that reputed company successful development of a therapeutics.
• Proven experience working effectively in matrixed organization, with strong communication and interpersonal skills.

What you can expect of us

As we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and reputed company a lasting impact with the reputed company team.

careers.reputed company.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

reputed company is an Equal Opportunity employer and will consider reputed company qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range