Director, Toxicology

Position Summary:

The Director (Head) of Toxicology will lead Apellis' toxicology efforts in characterizing and derisking new drug candidates to move into and through clinical development.

The position will play a critical role in leading and building the Apellis toxicology organization; driving the toxicology strategy to advance our growing pipeline of product candidates. In this role, the primary responsibilities will include strategy, planning, design/conduct and oversight of the investigative non-GLP and GLP compliant in vitro, small and large animal toxicology studies. These studies will support a broad range of activities across research, preclinical and development stages of the pipeline and across multiple therapeutic programs. The incumbent will be expected to explore novel technologies to characterize and derisk compounds of interest. In collaboration with other NCD colleagues (operations, DMPK, BA), will coordinate interactions with CRO's to ensure delivery of study results and reports consistent with program timeline. Additionally, the candidate will be accountable for the delivery of high-quality documents for regulatory filings (briefing books, IND/CTA, IB, NDA). He or she will be an integral part of a dynamic discovery and development team at Apellis and will be expected to work closely in cross-functional teams.

Key Responsibilities Include:

• Develop and oversee the strategy of nonclinical safety studies along with integrated project plans including milestones, timelines, resources and budgets.
• Design and execute nonclinical safety related activities from discovery through regulatory filings and to commercialization for all research and development programs
• Manage, mentor and develop junior toxicology and nonclinical colleagues
• Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets.
• Represent the toxicology function in cross-functional meetings both internally and externally; and to senior leadership.
• Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting all programs
• Bring innovative solutions that are 3Rs-centered, and reflect a welfare-oriented approach to animal-based research
• Provide expert toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications and help resolve nonclinical safety queries
• A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs; excellent data analysis and dissemination skills
• Clear and influential communicator: exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external groups and individuals

Education, Registration & Certification:

• MS / PhD Degree in Toxicology or Pharmacology or a related field

Experience:

• 
  

  Doctorate degree with 8+ years of scientific experience OR Master's degree with 10+ years of scientific experience and experience in a people manager role

  
  

Skills, Knowledge & Abilities:

• Solid toxicology background with experience in driving toxicology strategy through discovery into development.
• Experience in writing regulatory submissions, integrating toxicology with other nonclinical and clinical data
• Experience with siRNA preferred
• Experience working in Ophthalmology and/or Neurology Disease areas preferred.
• Ability to think out of the box and challenge established notions
• Demonstrated skills in toxicology functional leadership, people management, project and program management
• Strong leadership, team building, organizational, communication and interpersonal skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver
• Superior written and oral communication skills and the ability to work across different levels of management

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visithttps://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visithttp://apellis.comor follow us onTwitterandLinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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