Senior Director, Clinical Pharmacology

Senior Director, Clinical Pharmacology (PH-1035)

AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission. 

AN2 is seeking a Senior Director of Clinical Pharmacology to lead the clinical pharmacology aspects associated with the clinical development of novel antimicrobial drugs. This position will currently report to the Chief Medical Officer (CMO). 

This individual will be responsible for the development of the strategic, scientific, translational, and clinical development aspects of clinical pharmacology development plans across multiple infectious disease indications. Specifically, they will be involved in clinical development plans for all Phase 1–4 clinical trials of novel anti-infective drugs, including but not limited to strategy and planning, protocol development, and pharmacokinetic data interpretation. In addition, this individual will function as the Study Team Leader for the AN2 Phase 1 program, involving all Phase 1 Clinical Pharmacology studies. As part of the above obligations, they will be responsible for interfacing with internal medical, PK/PD, and nonclinical pharmacometrics team members, as well as external pharmacometric vendors and relevant consultants.

Responsibilities:

• Represent the Clinical Pharmacology function as a subject matter expert (SME) across the company and for all relevant clinical development projects, while maintaining the highest standards of scientific knowledge in clinical pharmacology 
• Provide strategic leadership and accountability for clinical pharmacology aspects of all AN2 Phase 1–4 clinical trials, including scientific input into study designs, clinical protocols and SAPs, PK/PD data interpretation, CSRs, and resulting publications and/or conference posters and presentations
• Work with key members of the clinical development team to ensure successful execution of Phase 1–4 clinical studies, including but not limited to the CMO, Clinical Microbiology, Clinical Operations, and the Chief Development Officer and nonclinical development team
• Function as the Study Team Leader for all AN2 Phase 1 studies
• Author clinical pharmacology related content for global regulatory submissions, including but not limited to INDs, IBs, NDAs, MAAs and PIPs
• Establish and maintain relationships with external pharmacometric vendors and consultants, including but not limited to CROs, consultants, and bioanalytic laboratories
• Contribute to the identification and implementation of clinical pharmacology technologies and analyses to drive optimal anti-infective drug development
• Attend meetings with external stakeholders (e.g., Scientific Advisory Boards, Investigator Meetings, study Site Initiation Visits, FDA and other regulatory authorities), as needed
• Contribute to the evaluation of early pipeline and in-licensing opportunities
• Provide clinical pharmacology advice and strategic input for external grant proposals and funding collaborations

Qualifications and Experience:

• PharmD or PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline
• Over 5 years of biotech/pharma drug development experience with deep expertise in clinical pharmacology; anti-infective development experience preferred
• Outstanding working knowledge of clinical pharmacology (pharmacokinetics, pharmacodynamics, translational medicine) and drug development principles
• Experience working across all aspects of drug development from early molecule discovery through Phase 4 preferred
• Track record of formulating, integrating and translating clinical pharmacology strategies into actionable deliverables
• Expertise in leveraging PK data and modeling to facilitate clinical development and registration, with an understanding of technical aspects of data analyses and associated software
• Knowledge of FDA, EMA and ICH regulations and ability to adhere to regulatory requirements
• Strategic leader, problem solver, and team player with a strong work ethic and a high degree of professional integrity; able to work in cross-functional global teams in a dynamic, fast-paced, and collaborative environment
• Excellent written and oral communication skills, with proficiency with MS Word, Excel, Outlook, and PowerPoint
• Occasional travel will be required; remote working is an option
• Current US work authorization required

By joining our small, highly dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.   

We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled 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 as provided to other applicants or employees. Please contact us to request accommodation.

Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.