The Senior Director of Pharmacology and DMPK reporting to the Head of Nonclinical Development will provide scientific, strategic, and hands-on leadership and execution of our R&D-wide strategy for Research. She/he will lead consulting and externally partnered resources, in Discovery and In Vivo Pharmacology, ADME, DMPK, PK/PD Modeling, Colony & CRO Management, Toxicology, Pathology & Safety. Key partnerships with nonclinical development, regulatory, clinical biomarkers and clinical pharmacology will be an important part of the role. She/he will hire, develop, mentor and retain key scientific while driving a high-performance, nimble culture that encourages innovation. This role will provide key leadership with the Nonclinical Development team with key roles in portfolio oversight, talent growth and development and company culture.

 Key Responsibilities:

• Lead Pharmacology and DMPK groups
• Accountable for the design, execution, analysis and interpretation of pharmacology, PK/PD, mechanistic, and safety studies for our programs and platforms.
• Provide Pharmacology, PK/PD, and DMPK expertise at all stages of discovery and nonclinical development for all programs and platforms from Research through
• Balance the internal infrastructure and capabilities vs. outsourcing; maintain an effective network of outside partners, collaborators and service organizations
• Lead our external collaborations on large animal studies. Execute CRO selection and supervision for toxicology studies as well as the design of non-GLP and GLP studies including NHP studies
• Partner with Nonclinical development to ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development.
• Provide support to Tech Ops (Manufacturing/CMC) to problem solve real-time issues with drug substance/drug product in stages of nonclinical development
• Ensure high quality review of key study documents, including protocols, study reports, regulatory documents, publications, and formal and informal presentations of study data.
• Represent Pharmacology during interactions/presentations with Regulatory Agencies
• Represent Pharmacology as a subject matter expert and thought leader. Develop and maintain relationships with KOLs, researchers, and academics.
• Foster and ensure a culture of transparency of progress against department infrastructural goals and various team goals, by modeling best practice for risk and issue identification, communication, and mitigation/management at the R&D Leadership Team.
• Effectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts.
• Provide guidance on potential business development opportunities. Participate in ad hoc due diligence activities and provide expertise

Qualifications:

• Advanced degree such as M.S. or Ph.D. (Ph.D. preferred) in biological sciences such as toxicology, pharmacology, or related discipline and 10 years of relevant experience in toxicology, pharmacology, or related discipline
• A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, in-licensing deals, and peer reviewed publications.
• Experience designing PK/PD studies including large animal studies
• Experience building and managing collaborations with scientists, contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
• Ability to communicate data and results both internally and externally and to manage collaborations with CROs, academia, and industry partners
• Ability to manage multiple therapeutic programs in parallel and prioritize according to the needs of the company while delivering on key milestones
• Strong appreciation for research but a focus on product development and IND-enabling preclinical studies
• Proven track record of being a strategic thinker and a tactical implementer. Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity.
• Comfortable in an entrepreneurial organization, wherein all leaders must take a hands-on approach and the environment is fast-paced and challenging