Head of Pharmaceutical Sciences

Head of Pharmaceutical Sciences

About Our Company

GV20 Therapeutics is a biopharmaceutical company with unique expertise in novel target identification and antibody drug discovery in Oncology. The company has established a proprietary STEAD drug discovery platform (Simultaneous Target Evaluation and Antibody Discovery) that harnesses the power of high-throughput functional genomics, big data and artificial intelligence. The STEAD platform has generated a robust portfolio against novel and challenging targets, with the lead program planned to enter phase I clinical studies in 2022.  GV20 is headquartered in Cambridge, Massachusetts, with a research site in Shanghai, China. For more information, please visit our website at http://gv20therapeutics.com.

At GV20, while we have diverse backgrounds, we share a common goal of advancing the frontier of science for cancer patients with the greatest unmet needs. As a GV20 team member, you will be part of a science-driven and collaborative culture, where you will regularly share your knowledge and expertise with a diverse team of research biologists, bioinformatics scientists, AI/machine learning scientists, clinical scientists, and business professionals. You will work in one of most vibrant life science hubs in the world, centered in a city with great culture, diversity and recreational offerings.

About the Position

The Head of Pharmaceutical Sciences plays a crucial role in translating scientific hypotheses into clinical possibilities. This individual leads a broad range of important translational activities that enable the discovery and development of safe and effective medicines at the right dose for the right patient. The ideal candidate thrives in a science-driven, patient-centric, dynamic, and fast-paced environment where cross functional collaboration and a growth mindset is critical for success.

Primary Responsibilities

• Take on accountability for the strategy and execution of key IND enabling activities, including toxicology/safety assessment (pilot and GLP), DMPK, bioanalytical assay development
• Take on overall accountability for clinical pharmacology, and clinical bioanalytical assay development and execution (e.g., PK, ADA, biomarker assays)
• Work closely with colleagues in other functional areas, expert consultants and CROs to ensure on-time and high-quality design and execution of the above activities, including completion of studies, delivery of reports and authoring of relevant sections of regulatory documents (e.g., IND/CTA, IB)
• Analyze and present related non-clinical and clinical data to relevant project teams, executive management, investors and partners as needed
• Represent Pharmaceutical Sciences in business development and financing activities
• Work with the executive team to build out the Pharmaceutical Sciences function in a stage-appropriate manner
• Keep abreast of latest trends in the industry and proactively develop strategies
• Implement and maintain industry leading standards for good clinical practice, compliance, and ethics

Required Qualifications

• Ph.D. or PharmD in Pharmacology, Pharmacokinetics, or a related field with a minimum of 10 years of relevant industry experience in drug development
• Functional expertise in pharmacology, including clinical pharmacology and preclinical DMPK, with extensive experience in selecting the right dosing regimen for the right patients
• Experience leading cross-functional pharmaceutical sciences teams to design and execute strategies in toxicology, DMPK, clinical pharmacology, bioanalytical assays
• Deep scientific expertise with a strong peer-reviewed publication record
• Strong experience with large molecule and oncology drug development required; experience in immuno-oncology strongly preferred
• Proven background of interaction with global regulatory agencies and driving programs through IND and CTA
• Extensive experience writing key study and regulatory documents such as IND and IB
• Experience in BLA/MAA filing is a strong plus Results-orientation and strong problem-solving skills
• Strategic thinker with proven ability to evaluate the strategic implications of decisions
• Strong leader with cross-functional leadership experience; experience recruiting, motivating, and retaining talents and build high-performing teams
• Demonstration of ability to be "hands on" and delve into details while keeping a clear strategic vision
• Excellent interpersonal skills and ability to collaborate effectively with a broad range of stakeholders in a matrixed environment
• Strong written and verbal communications skills including ability to communicate scientific information clearly and effectively
• The level and scope of the position will be commensurate with experience.

If you would like to join us in our mission to cure cancer, please click 'Apply.'  GV20 Therapeutics offers competitive compensation & benefits.  GV20 is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with the company’s health and safety obligations and/or applicable law or guidelines.