Director, R&D Operations

The Director, Preclinical Research and Development (R&D) will be responsible for translating novel therapeutic concepts into new drug candidates to build the corporate pipeline. This person will lead multiple programs through all phases of preclinical development that spans early compound discovery to IND-enabled drug candidates. Success in this role will require strong collaboration with internal team members and effective management external contractors across all drug development functions including medicinal chemistry and drug pharmacology.

• Manage multiple projects from early preclinical discovery concepts to Phase 1 ready therapeutic candidates
• Draft short- and long-term project timelines with critical path activities that reach key developmental milestones
• Working with senior team members to support management of the synthesis, characterization and formulation of new therapeutic compounds for preclinical and early clinical testing
• Design and manage in vitro experiments to characterize the pharmacology of new therapeutic compounds including stability, metabolism, mechanism of action, and toxicity studies
• Design studies in rodents and large animals to evaluate the pharmacokinetic, pharmacodynamic and toxicological properties of new therapeutic compounds
• Identify suitable disease models and design robust animal studies to evaluate the efficacy of new therapeutic compounds for target indications
• Analyze preclinical data from in vitro experiments and in vivo animal studies, interpret key findings, and adjust development efforts as needed
• Maintain detailed project budgets and work with corporate accounting to onboard new vendors, issue purchase orders, pay invoices, and track project spending
• Identify and manage contract research and development organizations to support all planned experiments and studies
• Identify and engage academic, industry and clinical consultants to support all aspects of drug candidate research and development
• Prepare presentations and give regular updates senior leadership that summarize progress, key findings, challenges, and planned/proposed activities
• Partner closely with internal teams to support intellectual property generation and fundraising activities as needed

Education:

Ph.D. or Pharm.

D. in a scientific or engineering discipline.

Experience:

• Minimum of 8+ years of experience in pharmaceutical research and development, with at least 5 years in a leadership or management role.
• Proven track record in preclinical development of small molecule drugs from early discovery to successful IND submissions.
• Experience leading multidisciplinary scientific teams and managing complex preclinical R&D programs.

Skills and

Competencies:

• Strong scientific acumen with a deep understanding of drug development processes for novel small molecule drug candidates.
• Strategic thinker with the ability to translate therapeutic concepts into developmental candidates.
• Problem solving skills with the ability to analyze a problem from multiple perspectives and then select the optimal decision.
• Exceptional leadership, communication, and project management skills.
• Demonstrated ability to work collaboratively across departments and with external partners.
• Knowledge of regulatory requirements and intellectual property considerations in pharmaceuticals.
• Entrepreneurial and self-motivated work style.
• Ability to work a hybrid in-office schedule.
• Preferred, but not required:
  Working knowledge of medicinal chemistry to guide the synthesis and characterization of new therapeutic compounds.