Come join a creative and collaborative team of scientists dedicated to leveraging emerging insights in RNA biology to develop novel classes of oligonucleotide therapeutics to treat human diseases and improve human health. In this role you will build a discovery DMPK team and work closely with internal partners and external collaborators to enable identification of multiple drug candidates for human clinical studies. Please apply if you feel that you can contribute to growing our team and advance our mission.
Flagship Labs 63, Inc. was founded by Flagship Pioneering, an innovation enterprise that conceives, resources and grows first-in-category life science companies (including the now familiar drug and vaccine innovator, Moderna Therapeutics). The firm’s institutional innovation foundry, Flagship Labs, is where teams of scientific entrepreneurs systematically evolve ideas and turn previously undiscovered areas of science into real-world ventures. Flagship has created over 100 scientific ventures resulting in >$19 billion in aggregate value, 500+ issued patents, and >50 clinical trials for novel therapeutic agents. Flagship’s portfolio companies include Sana, Seres, Codiak, Rubius Therapeutics, and Indigo Agriculture.
As an early member of a privately held, well-funded, early-stage platform biotechnology company, you will have significant influence on the platform development, drug discovery and development, and translation into the clinic along with the opportunity to grow as the company continues to expand. You will also benefit from opportunities to engage with the broader Flagship Pioneering ecosystem.
- Establish and develop a nonclinical DMPK, bioanalytical, and biomarker strategy that enables and supports oligonucleotide-based drug discovery and preclinical development, with a longer-term goal of enabling clinical studies and regulatory approvals
- Build, develop, and manage a highly skilled and motivated DMPK team that combines domain expertise, scientific excellence, and full integration with the FL63 R&D organization; ensure alignment with the company budget to meet company goals
- Establish and maintain effective relationships with contract research organizations (CROs) and external consultants. Design, contract and manage studies at CROs to deliver high quality in vitro and in vivo pharmacology data packages
- Manage scientific and operational activities related to nonclinical PK/DMPK and ADME, TK, and bioanalysis. Develop and maintain clearly defined study planning and execution capabilities that include study protocol preparation and review, project management, data analysis and reporting, study document management, and preparation of study reports
- Develop and apply biomarker strategies and methods during discovery and preclinical development that is appropriate for translation to clinical development. In collaboration with CROs and internal teams, manage all bioanalytical and biomarker activities, including development and validation of methods under GLP to support oligonucleotide-based drug discovery and development
- Develop analytical methods for the identification and quantification of oligonucleotides and their metabolites in biological matrices, cells, and nonclinical and clinical samples
- Author, review and approve study protocols and scientific reports that contribute to regulatory filings and support the advancement of molecules to testing in clinical trials
- Determine and model in vitro PK-PD relationship in vivo to establish clinical dosing approaches
- Establish a strategy for in vitro assays such as physicochemical evaluations, stability in cells and biological matrices, protein binding, P450 CYP inhibition, and transporter assays, that aid in prediction of toxicology safety margins and human dose calculations
- Operate in close collaboration with the Leadership Team, functional areas such as Medicinal Chemistry, In Vitro And In Vivo Pharmacology, Informatics, CMC, Clinical Development and Regulatory, and be a positive contributor to company culture in a matrixed team environment. Provide updates to the Leadership Team to define strategy/tactics and propose mitigation of roadblocks and risks
Qualifications and Skills:
- PhD in biology/chemistry-focused sciences and 7+ years of drug discovery or development experience working within or leading a DMPK group in the biotech or pharmaceutical industry
- Expert knowledge of oligonucleotide DMPK, ADME, and biodistribution properties and determinants
- Expert knowledge of bioanalytical methods for quantitative assessment of nucleic acids in various tissues and biological matrixes, including HPLC, MS, LCMS/MS, RT-qPCR, next generation sequencing, and hybridization approaches
- Expert knowledge of dose prediction and dose selection for animal studies in mice, rats, nonhuman primates and other model organisms and translation to human clinical studies
- Working knowledge of formulation and tissue delivery strategies for nucleic acids
- Working knowledge of biomarker types and method development
- Experience with and knowledge of GLP study design and reporting requirements
- Demonstrated ability to lead R&D teams and projects in matrixed environments
- Established ability to (1) identify suitable and relevant contract research organizations for each aspect of DMPK assessment, conduct due diligence assessment, and contract execution; (2) collaboratively develop study protocols; (3) establish working relationships and effective communication with consultants, study directors and CRO management; (4) ensure timely and comprehensive communication and information exchange and capture; (5) maintain fiscal diligence and ensure studies and contracted work remain within established budget
- Excellent organizational skills, effective project manager and leader
- Established and demonstrated ability of clear and concise written communication
Fast-acting/efficient. Moves quickly and proactively with a strong work ethic to produce high-quality results while fostering a positive work environment. Focuses on key priorities. Demonstrates tenacity and willingness to go the distance to get something done.
Integrity. Does not cut corners ethically. Earns trust and maintains confidences. Does what is right not just what is politically expedient. Speaks plainly and truthfully. Follows-through on commitments. Expects a high level of personal performance and team performance.
Critical thinking. Learns quickly. Demonstrates ability to proficiently understand new information and independently achieve meaningful outcomes. Able to structure and process qualitative/quantitative data and draw insightful conclusions.
Creativity & Innovation. Generates new and creative approaches to problem solving. Positive ‘can-do’ attitude. Views the toughest challenges as the greatest opportunities for personal growth and company innovation.
Teamwork. Fully engaged in facilitating personal and team success. Reaches out to peers and cooperates with the team to establish an overall collaborative work environment. Often solicits and responds well to constructive feedback. Possesses good written and oral communication skills with the ability to clearly and concisely convey ideas and opinions.
Flexibility/adaptability. Adjusts quickly to changing strategic and tactical priorities. ‘Wears multiple hats’ and is comfortable with ambiguity.
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.