Title: Head of Medical Affairs
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.
The Entasis Head of Medical Affairs will serve as the leader of Medical Affairs function and be responsible for developing the overall Medical Affairs capabilities, including internal operational functions and the field base Medical Affairs team. The Head of Medical Affairs will report to the Chief Medical Officer and will be responsible for medical and scientific team and project leadership, KOL engagement and partnership, innovation and industry influence.
- Contribute to developing Medical Affairs strategies, plans and tactics aligned with corporate objectives; ensure Medical Affairs team goals are achieved.
- Develop medical strategy, including, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform, aligned with product strategy
- Establish and lead Investigator Initiated Research (IIR) proposal process
- Manage execution of clinical studies (Phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with clinical development team
- Collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution
- Build, develop and retain a Medical Affairs team consisting of professionals who can infuse medical and scientific expertise throughout the organization via the projects they work on. Empower team members to make decisions and drive innovation.
- Responsible for managing and overseeing the exchange of medical and scientific data with physicians, regulators, payors regarding Entasis products.
- Work closely with the commercial organization to develop tactical plans for Medical Affairs team that’s aligned with corporate objectives.
- Communicate routinely with marketing teams to understand critical short- and long-term commercial goals, and ensure that presentations and communications with customers are in line with these goals and support commercial activities.
- Responsible for reviewing promotional and educational material for accuracy; supporting consultant and advisory meetings; and coordinating grant applications for scientific merit. Work multi-functionally with Quality, Regulatory, R&D, Clinical Affairs, and Marketing to support and guide the design, risk management, quality management.
- Advertising/promotion and evidence generation needed to achieve corporate objectives.
- Oversee and assist as needed with publishing post-market clinical studies, working closely with Clinical Affairs, Marketing, and other teams.
- Identify and recommend physicians or KOLs as potential participants of advisory boards and speaker bureaus to discuss Entasis products and other medical/scientific topics of mutual interest. Respond to and document unsolicited requests for scientific information regarding Entasis products, including those in development, as appropriate.
- Convey scientific and medical information to health care professionals to educate them on current topics in drug resistant infections, critical care, and antimicrobial stewardship and to ensure awareness and appropriate use of Entasis products.
- Deliver evidence-based scientific presentations to small and large audiences in a manner consistent Entasis’ goals and objectives.
- Contribute to the Entasis publication plan by ensuring publications, presentations, lectures, and posters based on the results of post-market clinical studies. Participate in developing, preparing, and presenting communication materials of study results.
- Assist in the organization and support of local, regional, national workshops and seminars using key opinion leaders as speakers/presenters and also participate as a speaker.
- Maintain clinical, scientific and technical expertise via attendance as directed at conferences, technical meetings and symposia, review of scientific journals and partnerships with product and technology experts.
- Perform other responsibilities as needed to drive company success.
- Previous significant experience in Medical Affairs related function
- MD degree preferred
- PharmD, PhD or medical sciences degree considered if experienced in Infectious Diseases or Antimicrobial drug development
- Background in FDA 21 CFR Parts 210, 211 and 820; ISO 13485; European Medical Device Directive; and IEC 60601-1 is preferred or previous experience in understanding global regulatory guidelines
- Background with drug/device combination product regulations and procedures is preferred
Skills and Experience:
- Demonstrated ability to work successfully in a team environment and communicate regularly with commercial and R&D team members.
- Ability to rapidly acquire knowledge of Entasis’ products as well as the competitive landscape in the drug resistant bacterial or antibiotic industry.
- Excellent verbal and written communication skills, with experience writing and publishing materials for peer reviewed publications preferred.
- Excellent public speaking and presentation skills required.
- Excellent scientific analytical skills.
- Self-motivated, success-oriented and demonstrated collaborative approach required.
- Remote or Home-office based position
- Travel can be from 10 - 25% of time, consisting of customer meetings and conference attendance
Entasis is an equal opportunity workplace. 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.