Director, Clinical Pharmacology

Position Summary:

The Director (Head) of Clinical Pharmacology will have a lead role in advancing our growing pipeline. The ideal candidate will champion the use of clinical pharmacology expertise and model-informed drug development (MIDD) strategies to enhance the development of novel therapies across all phases of R&D and therapeutic areas, including neurology, ophthalmology, and rare diseases.

Key Responsibilities Include:

• Lead and represent clinical pharmacology on late-stage research and clinical development teams; and represent clinical pharmacology to executive leadership.
• Lead Clinical Pharmacology program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory submission (e.g. NDA, MAA) document preparation.
• Provide strategic vision, goals, and practices, and be responsible for people management within the clinical pharmacology function, as needed.
• Accountable for ensuring that appropriate PK/PD analyses are adequately planned, conducted, and aligned with the research, clinical development and filing strategies.
• Provide clinical pharmacology components of protocols, investigator's brochure and other regulatory documents.
• Work in close partnership with the research and development teams to enhance the development of drug candidates from FIH to registration.
• Be the subject matter expert in clinical pharmacology and PK/PD modeling.
• Manage and be accountable for pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity data analysis and interpretation of results for select clinical trials.
• Lead Phase 1 studies in healthy volunteers.
• Maintain a high standard for clinical practices, compliance, and ethical standards.

Education, Registration & Certification:

• PhD, PharmD, or MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines

Experience:

• 10+ years of industry/biotechnology experience in clinical pharmacology.

Skills, Knowledge & Abilities:

• Project, program, and people/functional leadership skills.
• Experience running Phase 1 Healthy volunteer trials.
• Demonstrated ability to develop strategy and work independently in fast paced and cross functional environment.
• Demonstrated experience in writing, presenting, and discussing model-informed drug development strategies and clinical pharmacology with both internal and external stakeholders, including executive leadership and regulatory authorities.
• Strong analytical skills and ability to interpret complex clinical data sets coupled with excellent written and verbal communication skills.
• Proven ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs.
• Strong technical proficiency in PK/PD analyses (PopPK, PK/PD modeling and simulation) and software (e.g., Phoenix, R, NONMEM)
• Proven ability to work with a high level of integrity, accuracy, and attention to detail while executing corporate objectives and goals.
• Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing internal/external partnerships and cross-functional matrixed relationships.
• Entrepreneurial, enjoys working in a fast-paced environment.
• Demonstrated application of critical thinking skills.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

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.