Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat multi-drug resistant, Gram-negative infections. In light of recent positive Phase 3 data for our NDA-candidate, plazomicin, and a growing pipeline that includes two small molecules in early development and multiple large and small molecule discovery programs, we are looking for an accomplished scientist to lead our growing clinical pharmacology group.
We seek a highly motivated and driven scientist with proven leadership abilities. This position will provide an exciting opportunity to lead an experienced clinical pharmacology team as they file the NDA and MAA for plazomicin, advance early development programs through IND to clinical proof of concept, and partner with the research group as they look to translate their work into the clinic. If you are passionate about science, are strategically agile, like working in a team, are looking to grow in your career and are committed to performing rigorous experiments that inform drug development, then this is the place for you!
- Accountable for the scientific output, conduct and resourcing of the clinical pharmacology group.
- Build and lead a clinical pharmacology group, growing the team’s existing high level of scientific excellence to global recognition as the #1 clinical pharmacology group in terms of drug development for areas of critical unmet need, academic accomplishment and camaraderie.
- Take an active role and pride in developing scientists both within the clinical pharmacology function and across the business, helping them grow their careers and step up to fill critical business needs.
- Leverage prior experience with regulatory agencies and on cross-functional development teams to help the function set appropriate strategy for dose justification, clinical pharmacology plans, and regulatory filings.
- Represent the clinical pharmacology function as a standing reviewer on Achaogen’s scientific and development review committees, providing technical guidance to individual programs, endorsement of resource plans and portfolio prioritization.
- Lead by example in maintaining the effective partnerships between clinical pharmacology and related functions in research and development.
- Manage the clinical pharmacology function including responsibility for budget and hiring.
- Collaborate with vendors, consultants and collaborators to accomplish goals and deliverables of the department.
- Present operational plans, scientific data and strategy to internal and external audiences, including regulators, key opinion leaders, partners and executives.
- Review relevant reports and other scientific data for regulatory filings.
- Participate in in-licensing and out-licensing activities.
- 10 or more years of relevant industry experience in clinical pharmacology, pharmacometrics, or related discipline, including experience with small molecules and antibody therapeutics.
- 5 or more years of management experience including at least 2 years leading a clinical pharmacology department.
- Proven track record with regulatory deliverables and interactions, including IND filings and significant contributions to small molecule NDA/MAA filings.
- Record of scientific excellence, including publications in top tier journals.
- Experience with anti-bacterial and/or anti-infective drug development.
- Candidates with significant experience in nonclinical drug metabolism and pharmacokinetics and bioanalytical method development may also be considered for an expanded leadership role that would include these functions.
- PharmD or PhD in pharmacokinetics, pharmacometrics, clinical pharmacology or a related scientific field.
Preferred Additional Skills:
- Motivated and passionate about making a difference for unmet medical needs.
- Strong oral and written communication skills and business partnering ability.
- Strong interpersonal skills and ability to work with others in a positive, collaborative manner, inspiring trust and confidence with colleagues.
- Willingness to be a “hands-on, roll-up-your sleeves” leader.
- Committed to values of integrity, accountability, transparency, scientific rigor and drive.
- Current US work authorization required.
- Ability to travel domestically and internationally.