Vice President, Nonclinical Development & Translational Medicine

Propella Therapeutics, Inc., is recruiting a VP of Nonclinical Development and Translational Sciences to lead the biological evaluation of the company’s oncology pipeline.  This pipeline consists of prodrug candidates rationally designed to utilize lymphatic targeting for delivery. We seek a biology leader who has worked in a private or public biotechnology company or academic setting.  They should be knowledgeable about oncology drug development and the associated regulatory approval process.

This individual will provide biological research and development leadership for the selection and development of best-in-class, small molecule prodrugs for cancer indications. The VP will report to the CEO, partner with the Senior Leadership Team and contribute to the company's business vision to develop oncology products that address high unmet medical need. Propella works closely with principal academic collaborators, consultants, KOL Advisors, and CRO partners to advance the development of its product candidates.  The VP will partner with this network to conceive, initiate and oversee in vitro and in vivo nonclinical studies and implement a translational science strategy from concept through IND submission and into early clinical development via a rigorous solicitation and review of vendor proposals, including the design and execution of relevant studies. The VP will provide strategic and tactical oversight for all nonclinical safety and efficacy studies, help prioritize and select IND candidates, and work to extend the Company’s network of consultants, CROs, and KOL advisors. The VP will have oversight responsibilities for the biological characterization of development candidates and study strategy from exploratory through IND enabling and clinical proof of concept studies.

The VP will present study results to a variety of audiences including the Board of Directors, the Oncology Advisory Board, at medical and scientific conferences, and to investors.

Responsibilities:

• Oversee and refine the biological functional capability, which includes a high-performing Team of internal experts and an external network of Consultants and Partners, as well as develop industry-leading preclinical strategies to support candidate selection from concept through clinical POC
• Collaborate closely with other members of Propella’s leadership team to develop and implement an overall development and regulatory strategy for new prodrug candidates
• Partner with Team members to define the pharmacological benefits and safety risks of target engagement and appropriate in vitro and in vivo models
• Lead and oversee the development, execution and interpretation of nonclinical studies to cost-effectively drive candidate go/no go decisions and development prioritization
• Develop and manage relationships with academic, CRO, and consultant partners
• Identify external laboratories for nonclinical and IND-enabling study execution; coordinate placement and monitoring of studies, and the review of results
• Contribute to the development of a strategy for the identification of efficacy biomarkers and endpoints that translate into the clinical development program
• Integrate bioavailability and DMPK data to establish PK/PD relationships in support of early allometric scaling of a human dose
• Estimate of safety margins based on available data
• Provide biology leadership and communicate the impact of study results to the Propella Team and external audiences including investors and potential corporate partners

Qualifications:

• MD or PhD degree in pharmacology, toxicology or related discipline plus 10+ years of relevant experience, including in a biopharma environment
• In-depth knowledge of PK, PKPD, in vitro and in vivo metabolism and toxicology as well as regulatory expectations for IND filings
• Familiarity with cancer biology and the mechanistic pharmacology of diverse oncology therapeutics
• Proven experience progressing preclinical oncology candidates into the clinic, including the management of IND studies
• Familiarity with parenteral drug delivery options, and the lymphatic system specifically
• Experience preparing INDs and prior regulatory interaction participation including the preparation of documents for regulatory agencies
• Strong organizational ability to prioritize and deliver data in a timely manner
• Strong interpersonal and oral and written communication skills
• Ability to command the respect of peers and a variety of external audiences

Requirements (Must Haves):

• Prior experience as a Biology Senior Leader in a biotech or pharmaceutical company
• Proven scientific accomplishment including a track record of high-quality publications
• Strategic problem solver who inspires confidence, creates trust, and works well under pressure
• Experience and ability to recruit new Consultant and Advisory talent into the organization
• Ability to work effectively both independently and collaboratively in a dynamic, team-based environment
• Ability to work effectively and professionally with external CROs and collaborators
• Must be willing to spend a minimum of 4 to 6 days per calendar month in the Company’s office near the Research Triangle area of North Carolina
• Up to 15% travel

Requirements (Nice to Haves):

• In-depth knowledge of the lymphatic and circulatory systems
• Help recruit new staff when needed