Title: Head of Pharmaceutical Sciences
Location: Waltham, MA
Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO. The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections) and zoliflodacin (targeting Neisseria gonorrhoeae). Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections.
Entasis Therapeutics is seeking an experienced and effective leader to play a very significant role in driving innovative products from early and late-stage discovery through product approval. This individual will be accountable for chemical development, formulation development, process development, and analytical development. The Head of Pharmaceutical Sciences will play a pivotal role in shaping the direction and priorities of the R&D organization and help translate these priorities to actions that enable Entasis to deliver on key objectives across the portfolio.
- Design and champion CMC roadmap for the company
- Apply robust science to effective pharmaceutical product development
- Establishing a drug substance and drug product strategy and, in partnership with business development, negotiate contracts with CROs/CMOs
- Hire, retain, lead all talent in the Pharmaceutical Sciences function
- Designing and overseeing relevant studies across the portfolio with regards to pharmaceutical development sciences
- Oversight/review (and author, as appropriate) all relevant CMC sections for regulatory submissions to support our product candidates
- Reviewing study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with appropriate regulations and guidelines for CMC related issues.
- Identify execution risks and develops contingency plans as needed
- Partner with executive team in reaching timely, data-driven decisions with regard to pharmaceutical development and drug manufacture.
- Establish development and operations for chemical development, formulation development, process development, and analytical development
- Ensure robust planning and execution of product development efforts across the organization’s portfolio of development stage product candidates
- Help create, and deliver to, the overall R&D strategy and key priorities
- Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to further help advance R&D goals
- Maintain a robust longer-range CMC plan to support the broader organizational objectives
- Ensure effective communication and alignment of efforts both within clinical operations and key partners internal and external (particularly regulatory and quality assurance).
- Act as liaison and/or provide support to team members to act as liaison with FDA and other regulatory agencies for CMC issues
- Work closely with organization partners as well as internal colleagues to ensure effective working relationships and to proactively identify and mitigate risks to the conduct of work to advance our products in a timely manner
- Develop and track Pharmaceutical Sciences budget with finance. Secure approval of changes arising throughout the year due to changing conditions/plans
- Perform on-site visits with key manufacturing providers as needed.
- M.S. or Ph.D. in pharmaceutical sciences, chemistry or engineering with significant experience in industry is essential
- Strong people management skills with previous experience developing and mentoring employees
- Demonstrated ability to be effective in an entrepreneurial, fast-paced environment
- Comprehensive understanding of all aspects of Pharmaceutical Sciences including chemical development, formulation development, process development, analytical science, supply chain, regulatory, and quality for small molecule products
- Experience with injectable products is required. Experienced with oral products is highly preferred.
- Experience with regulatory submissions, interactions with regulatory agencies regarding CMC issues at all stages of product development
- A proven track record of successfully progressing drug candidates from IND through NDA submission
- Excellent analytical, communication, presentation, writing, and leadership skills
- Experience in writing CMC regulatory documents
Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538
Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off.
Entasis is an equal opportunity workplace and participates in E-Verify. We welcome diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.
Entasis considers the health and safety of it’s employees and community a top priority. To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation. If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.