VP of Development (Pasadena CA | $200K-$325K DOE)
SNAPSHOT:
Are you looking for an opportunity to join cutting-edge pharmaceutical chemistry team that’s developed a proprietary platform technology for creating small molecules to treat patients with unmet medical needs? THEN READ ON! Our client’s technology allows unprecedented structural tailoring of small molecules that will enable the development of molecules with better target receptor docking and other desirable properties! The Vice President of Development will oversee the clinical translation of novel therapeutics in oncology using companion/complementary diagnostics by working closely with the company’s executive leadership, preclinical team, founding oncologists, and external regulatory resources. The incumbent is accountable for ensuring that Clinical Development Plans (CDPs), clinical trials and protocols are informed by regulatory guidelines and strategic regulatory opportunities. She/he will help to synthesize the guidance of the various stakeholders and build consensus for clinical and regulatory strategies on multiple simultaneous programs.
Immediate fast-track opportunity for a VP of Development in Pasadena CA who possesses:
MD, or PhD in Life Sciences, with experience in oncology drug development.
5+ years of experience working in a pharmaceutical or biotech in clinical development or translational medicine, preferably at least in part in a small biotech company.
Preferred Qualifications
Extensive knowledge of US FDA/EMA drug/diagnostic device development process, regulations and guidelines. Previous experience working with CDER, CBER and CDRH is strongly preferred.
Extensive experience with collaboration in pharmaceutical drug and diagnostic discovery and development, innovative first-in-human clinical trial design and translational medicine under an accelerated approval paradigm in oncology is strongly preferred.
Key Responsibilities Include:
Critical team member in developing innovative clinical study designs.
Responsible for developing CDPs which synthesize biomarker implementation with companion diagnostic integration, histology selection and clinical trial design
Instigate Strategic CDPs and filings to accelerate programs when possible including: orphan drug designation, priority review, breakthrough therapy, accelerated approval and fast track.
Initiate and foster relationships with academic partners, consultants and other external parties to evaluate feasibility and optimization of CDPs, enable access to samples, and participate in scientific exchange.
Provide strategic regulatory leadership for all clinical development projects, including overall global regulatory strategy, drug/companion diagnostic development planning, compliance to domestic and international regulatory requirements, and regulatory risk assessments and mitigation for all Company programs.
Lead communications with regulatory agencies. Prepare briefing and regulatory documents for regulatory agencies. Respond to regulatory agencies with intelligence and diplomacy.
Work closely with the research team to discuss targets, results of in vitro and in vivo preclinical studies and predictive biomarker strategies supportive of translational CDP.
Ensure that all non-clinical programs such as pharmacology, toxicology, drug metabolism and pharmacokinetics are appropriately informed and structured to support CDPs.
Contribute to corporate infrastructure via development of policies, SOPs, work instructions, etc.
Develop CDP budget in collaboration with team. Seek ways to reduce costs and improve efficiencies.