Vice President of Quantitative Clinical Pharmacology, Translational PK/PD, Modeling and Simulation

Clinical Science        ·       South San Francisco, CA       ·       Full time

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

We are a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegeneration. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The company is developing a broad portfolio of product candidates that is validated by human genetics and recruits the brain’s innate immune system to prevent, halt, and reverse emerging brain pathologies in multiple neurodegenerative diseases.

To date, Alector has advanced four product candidates for the treatment of Alzheimer’s disease, frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and Parkinson’s disease (PD) into clinical trials, ranging from Phase 1 to 3, and the company intends to advance three new programs into clinical trials over the next 12 months. As part of Alector’s research and expertise in innate immune system biology, the company has identified multiple distinct therapeutic targets that are shared between the central and peripheral innate immune systems, creating an opportunity to develop certain of Alector’s targets and candidates may be efficacious in both neurodegeneration and cancer. Of the three new programs that will enter the clinic in the next 12 months, two are initially being developed for the treatment of cancer.

The Position

The VP of Quantitative Clinical Pharmacology and Translational Science will have end to end strategic and scientific accountability for the understanding of the disposition of our drug candidates and the relationships of drug exposure to the safety, pharmacodynamics and  efficacy during preclinical and clinical stages of development. This position will be responsible for providing PKPD support to all preclinical discovery, early development, and late development programs. The ideal candidate will apply state of the art Model-Based Drug Development principles as needed and combine  important aspects of therapeutic area pathophysiology to optimize dose/dosing regimen for target patient populations/sub-populations while promoting efficiencies in both preclinical and clinical study designs.

The leader will be accountable for the design, implementation, and interpretation of the studies and results from preclinical PK, TK and clinical studies; enable dose selections, clinical study designs, authors sections of regulatory submissions and acts as a subject matter expert for interactions with global regulatory agencies. In addition, the VP will also interact and collaborate with appropriate counterparts working within our partnering companies. The VP  will be part of a vibrant and experienced team in R&D driving the scientific understanding, development, and registration of novel therapeutics in a company dedicated to finding novel treatments for neurodegeneration and cancer.

We are looking for an individual that is capable and interested in   fostering scientific curiosity, critical thinking, and self-motivation within the team they form and in which they participate . In this position, the VP will identify critical staffing needs and hire top talent to fulfill those needs. The desired candidate will have an exceptional industry reputation and a wide-ranging network of individuals in the area of preclinical and clinical development, extensive experience working with CROs and significant relevant experience in developing novel therapeutics. Detailed working knowledge of global regulatory practices is essential. Excellent communication collaboration and leadership skills are important in this role.

During the first year, your goals will include:

• Provide strategic insight and technical leadership within your function.
• Lead the design and analysis of PK and TK data in our preclinical studies and build PK/PD models to increase our understanding of the relationship between drug and response (activity/safety)
• Lead the development and execution of the translational PK/PD strategy for preclinical stage programs to ensure adequate knowledge exists for transition to clinical development, including nonclinical PK characterization, human PK projection and first-in-human dose selection and justification
• Develop and execute mechanistic PK/PD models of neurodegenerative diseases, including physiologically-based pharmacokinetic (PBPK), quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine-learning/deep learning and other state of the art quantitative techniques
• Advance clinical candidates in the company portfolio; accountable for nonclinical PK sections of regulatory filings (IND/CTA), relevant nonclinical reports and contributions to clinical protocol development
• Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan.
• Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, exposure-response analyses, PK and immunogenicity characterization and system pharmacology, to integrate nonclinical data and clinical data to guide dose/schedule optimization and recommended phase 2 dose and schedule (RP2Ds) selection.
• Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology (including protocol, IB, briefing package, etc) and responses to regulatory questions.
• Lead and manage an internal team and engage and work with consultants and/or CROs on activities to complement in-house knowledge/expertise and capacities.
• Mentor a team that is representing the function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
• Manage and mentor junior scientists to enable overall effectiveness and efficiency of the NDCP organization.

We’d love to hear from you if you have:

• A Pharm.D. or Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related scientific discipline with at least 15 years of relevant industry experience.
• Demonstrated experience and track record in designing and executing dedicated clinical pharmacology studies and clinical pharmacology components of clinical studies.
• Track record of applying modeling and simulation methodologies to inform and accelerate drug development.
• Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
• Strong leadership and interpersonal skills, and ability to influence development project and management teams.
• A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment
• Ability to manage and mentor a team of scientists.

#LI-BL1

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

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

Please click here to apply.