What if… you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainability?
Montai Therapeutics Carolina and references is a privately held, early-stage biotechnology company developing a platform for understanding and leveraging complex molecular interactions within organisms to solve global challenges in human health and sustainability. The company leverages a multidisciplinary approach that integrates tools ranging from machine learning and big data to multi-omics and high-throughput screening.
At Montai, we nurture a bold, spirited and leading-edge culture dedicated to strengthening human health:
- We are one team with omnidirectional trust, empowered and accountable
- We are strong as individuals but stronger as a team and we are committed to excellence
- We have a sense of urgency and persistence and we are crazily confident that we can make a difference
- We need to be comfortable with the uncomfortable and be rigorous and we recognize that failure is data
- We care for diversity in people, thought, personality, opinions, background and distinctiveness
- We have a sense of humor to help us manage through our strategic noise
Reporting to the Head of DMPK at Montai Therapeutics, the ideal candidate will lead DMPK activities to support research and early development projects in Montai Therapeutics’ Drug Metabolism and Pharmacokinetics (DMPK) team. We expect this person to collaborate with team members across other functions such as medicinal chemistry, formulation, safety assessment, pharmacology and clinical development to advance Montai’s pipeline. We also would expect the ideal candidate to design and manage external ADME/PK studies at multiple contract research organizations.
Responsibilities:
- Initiate and conduct in vitro and in vivo ADME/PK studies
- Interact and oversee outsourcing ADME/PK studies as a study monitor
- Prepare, review, and approve GLP/non-GLP-related documents (SOPs, protocols, amendments, reports, etc.) generated internally or externally
- Assist the Head of DMPK department in establishing a solid research and development system and in prioritizing and forecasting workload, and ultimately meeting group, departmental, and company goals
- Serve as a project team representative: Ensure effective achievement of lead optimization goals and candidate selection in late-stage research. Coordinate and interact with other department members for planning GLP or non-GLP nonclinical studies, clinical studies, TK/safety, and DMPK-related activities
- Oversee ADME/PK data entry to internal database
Qualifications:
- Advanced degree required . in pharmacology and ADME/PK related discipline with a minimum of 10 years of relevant experience in DMPK and/or relevant experience.
- Depth understanding of Pharmacology/ADME/PK and GLP regulations and relevant regulatory guidance/ guidelines
- Depth understanding bioanalysis with LC/MS/MS (or HRMS), data interpretation and troubleshooting
- Strong communication and interpersonal skills. Also, ability to present complex data to scientific and non-scientific members.
- Hands-on experience with WinNonlin/Phoenix. Experience in simulation software (e.g. PBPK simulator) is a plus.
Flagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. In 2021, Flagship Pioneering was ranked 12th globally on Fortune’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.
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.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.
Top Skills
What We Do
Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability.
Since its launch in 2000, the firm has applied a unique, hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by >$3 billion of aggregate capital commitments, of which over $1.5 billion has been deployed toward the founding and growth of its pioneering companies alongside >$10 billion of follow-on investments from other institutions.
The current Flagship ecosystem includes Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Moderna Therapeutics (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS).
