Ph.D. or Pharm.D. in a scientific or engineering discipline.
8+ years in pharmaceutical R&D, with 5+ years in a leadership role.
Proven experience in preclinical development of small molecule drugs.
Experience leading multidisciplinary scientific teams.
Strong understanding of drug development processes and regulatory requirements.
Responsibilities
Manage projects from early discovery to Phase 1 therapeutic candidates.
Draft project timelines with critical path activities.
Design and manage in vitro experiments for pharmacological characterization.
Conduct studies in rodents and large animals for pharmacokinetic evaluation.
Analyze preclinical data and adjust development strategies accordingly.
Maintain project budgets and manage vendor relationships.
Prepare presentations for senior leadership on project progress and challenges.
Benefits
Hybrid in-office work schedule.
Opportunity for bonus and equity compensation.
Full Job Description
Position Overview
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 of external contractors across all drug development functions including medicinal chemistry and drug pharmacology.
Key Responsibilities
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
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 to 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
Qualifications
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
Working knowledge of medicinal chemistry to guide the synthesis and characterization of new therapeutic compounds
Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.
