Vice President, Translational Sciences and Nonclinical Development
Our client is a pharmaceutical company. They have asked us to assist them in a search of a Vice President, Translational Sciences and Nonclinical Development.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Leads the strategic plan and implementation of the company’s preclinical pharmacology and toxicology programs in collaboration with a range of internal and external partners.
- Works closely with different groups to ensure robust data is generated to support dose selection for clinical programs, and ultimately NDA/BLA/MAA approvals.
- Partners with different clinical and safety groups to conduct safety toxicity/safety assessments.
- Collaborates with the team to ensure coordination of manufacturing activities.
- Works closely with the team to offer support for toxicology and pharmacology studies and to design in vivo studies in support of formulation transitions.
- Serves as Translational Science and Nonclinical Development subject matter expert on project teams supporting the discovery and development of novel biologic therapeutics in infectious diseases.
- Keeps abreast of novel scientific developments in the field, and shares new information with project team and management as appropriate.
- Manages an integrated team of colleagues and oversees the study design, executes and interprets results and presents data at relevant project team meetings as well as to senior stakeholders in the Company.
- Ensures oversight of CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies and ensures that studies are delivered within agreed quality, cost and timeline parameters.
- Coordinates CRO selection.
- Develops and reviews study protocols.
- Ensures that reagent generation, method development and sample analysis timelines are met.
- Works closely with contracting team to ensure timely preparation of MSAs, SOWs, and work orders.
- Reviews and processes invoices for approval.
- Oversees assay development, validation and sample analyses.
- Reviews study progress, summarizes data and finalizes study reports.
- Spearheads interactions with regulators regarding Preclinical Development and author relevant sections of regulatory submission documents.
- Represents the company externally at scientific meetings, regulatory agency meetings, grant defense and review meeting, partner interactions and with external experts, KOLs and other stakeholders.
- Writes and presents abstracts at scientific meetings and manuscripts as agreed with the EVP of R+D and the company’s senior leadership.
- Works with GLP Quality to ensure non-clinical quality and compliance and development of the company’s SOPs to ensure compliance with all applicable regulations, SOPs, policies and guidelines, as needed.
- Presents R&D strategy and timelines to C-Suite and BOD when appropriate.
- Requires a PhD in Pharmacology, Toxicology, or other fields related to life sciences.
- Must have at least 10 years of relevant experience in pharmaceutical drug development.
- Requires extensive experience and expertise in animal models for infectious disease drug development, including PK/PD.
- Must have a demonstrated track record of successful delivery of completed preclinical programs.
- Requires experience with the generation of PK/PD data in the animal setting and the application of this information to support anti-infective drug development and approval.
- Must have an in depth understanding and experience in the design, development and conduct and interpretation of non-clinical toxicology and safety pharmacology studies.
- Experience with toxicological assessment of biologics (protein-based therapies) is strongly preferred.
- Must have a broad experience in the development and validation of relevant assays on multiple technology platforms.
- Requires thorough knowledge of GLP standards, and a solid working understanding of regulatory requirements for preclinical development of biologics and anti-bacterial products.
- Must have extensive experience with the design and conduct of animal models of bacterial infection.
- Experience in the preclinical/toxicologic assessment and development of biologic compounds is strongly preferred.
- Requires a demonstrated track record of a successful completion of IND-enabling studies and pre-IND meetings leading to IND opening Phase 1 clinical programs.
- Must have experience in supporting BLA/MAA submissions and participation in related interactions with FDA/CHMP.
- Requires a proven track record as a people manager and team leader.
- Must have experience in the conduct of screening toxicity studies, as well as IND-enabling toxicity/toxicokinetic and safety pharmacology program, including safety assessments.
- Requires demonstrated leadership and management skills (including both direct and dotted line reporting relationships).
- Must be able to see the big picture, and connect the dots, while maintaining sufficient focus on details.
- Requires the ability to successfully work with a collaborative, fast‐paced project team in an entrepreneurial work environment.
- Must have the ability to influence, negotiate and successfully communicate with both internal and external stakeholders.
- Requires excellent organizational, planning, and project management skills.
- Must have strong communication, both oral and written, as well as excellent interpersonal skills.
- Requires the ability to present complex pharmacology and toxicology data to a wide range of audiences.
- Must have a proven track record making decisions in an autonomous manner.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.