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Director/Senior Director, DMPK
(Job Code: DMPK)

We are seeking an experienced leader to oversee all DMPK activities supporting the advancement of our multi-therapeutic pipeline of compounds through preclinical translation and into clinical development. The successful individual will have a proven track record of innovation and creativity, and a deep knowledge of new technologies and cutting-edge approaches to address in vivo pharmacology, drug metabolism and PK/PD issues. Candidates must also exhibit excellent oral and written communication skills, as this role requires the development of study protocols, reports, project and regulatory summaries, development plans and IND filings.

Responsibilities:

• Establish and manage optimal ADME, PK and PK/PD strategies, including study design, implementation, timelines and budget, for our proprietary Stapled Peptide technology platform across multiple drug discovery programs;
• Supervise and mentor other scientists and create a positive, development-focused team environment;
• Work across disciplines to select, develop, and implement PK/PD models in collaboration with CROs and academic partners.
• Coordinate activities with internal bioanalytical and chemistry resources, and manage in vivo and other experiments conducted with Contract Research Organizations;
• Work closely with counterparts in clinical research and partnered discovery programs to translate preclinical results to clinical success;
• Author the pharmacokinetic, toxicokinetic, and ADME sections of briefing books and other regulatory submission documents;

Requirements:

• PhD in Pharmacology, Biology, Pharmaceutical Sciences or a related field (e.g. PharmD, Biochemistry, or equivalent) with 10+ years of industry experience demonstrating significant expertise and in-depth knowledge in PK, absorption, distribution, metabolism, and excretion (ADME) of preclinical lead compounds and/or development candidates.
• A minimum of 10 years of pharmaceutical industry experience with respect to DMPK, including project management and briefing book/IB preparation, and IND/NDA submissions;
• Full understanding of PK/PD modeling and pharmacometrics, with the ability to quantitatively evaluate dose/PK/response in preclinical studies to inform the direction into the clinic;
• Hands-on experience with modeling and simulation using software such as SAS, NONMEM, Splus, R, Monolix, TS2 and Phoenix;
• Identify statistical input, where appropriate;
• Prior peptide experience is highly desired, but not absolutely required;
• Excellent communication and interpersonal skills

Join us at Aileron and be part of a team that is creating a new class of drugs. Our entrepreneurial culture provides an opportunity for immediate growth and impact, and directly rewards creativity and drive. Our state-of-the-art labs are conveniently located between Harvard and MIT, and we offer a strong compensation and benefits package.

To apply, please forward your cover letter and cv noting the appropriate Job Code to careers@aileronrx.com.

Aileron will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. Aileron is not responsible for any fees related to resumes that are unsolicited.