Ensem Therapeutics is seeking a VP and Head of Clinical Development. The successful candidate will be a highly motivated & results-driven individual with extensive oncology clinical development experience in biotech and/or pharma. S/he will work closely with preclinical Research team as well as external clinical consultants, drive the strategic planning and execution of first-in-human clinical trials through registrational studies.

· Review preclinical data and design first-in-human clinical trials for best- and/or first-in- class Oncology small molecules.
· Along with the project team, external consultants, and academic thought-leaders, the candidate will design clinical strategies to define proof-of-concept, as well as registration, and will execute on these strategies.
· Drive clinical study design, lead study protocol development, and collaborate with cross- functional teams and clinical investigators in all study activities.
· Oversee management of clinical trials, including investigator/site selection, patient recruitment strategies, milestones, and develop effective working relationships with clinical investigators, thought leaders, clinical consultants and CROs.
· Accountable for the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
· Direct, hands-on involvement in all aspects of clinical study conduct, including data review, analysis, and reporting that conforms to the highest ethical, safety, and quality standards and in compliance with regulatory standards.
· Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
· Engage external business partner(s) and exert influence on joint clinical development strategy and study designs, with the goal of advancing ENSEM molecule from early clinical trials to final approval.
· Remain current on the therapeutic landscape in the relevant therapeutic areas in order to provide input and guidance for the strategic direction.
· Promote open, collaborative and entrepreneur culture.

· MD or MD PhD with board certification in the field of Medical Oncology.
· 5+ years of experience in the design, execution, and reporting of clinical trials in oncology preferably with small molecule drugs in pharmaceutical/biotech industry (or a combination of academia and industry).
· Excellent scientific knowledge relevant to clinical oncology, especially in the development of targeted therapies.
· In-depth knowledge of medical aspects of GCP, ICH, FDA, EMA, and other Country-specific guidelines and regulations for global submissions.
· Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents.
· Excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment and with contractors and CROs.
· Strong interpersonal, influencing, presentation, and written communication skills.
· Excellent organizational and time management skills. Dynamic, self-motivated, innovative, and critical thinker.
· Ability to travel to clinical trial sites, Conferences, Advisory Board meetings, etc.

Ensem Therapeutics is seeking a Director Strategic Business Development. The successful candidate will be a results-driven & dynamic individual with extensive business development experience in biotech and/or pharma. S/he will conduct market analysis and work closely with ENSEM R&D team, to identify, evaluate and establish external collaborations to advance ENSEM’s home-grown programs.

· Participate in the development and execution of ENSEM corporate business strategy.
· Build strategic business proposal/recommendation to the Executive Management, with solid supporting data.
· Spearhead ENSEM business development from market forecasts, competitive intelligence analyses, valuations and scenario modeling, contract execution, detailed tracking of progress/status, to alliance management.
· Lead out-licensing (or in-licensing) business efforts for multiple products and indications, by championing term sheet negotiation and drafting agreements in close collaboration with internal teams, including R&D, legal, finance and others.
· Manage external interactions with partners and maintain dashboards on the health and progress of alliances, including tracking of development milestones and fulfillment of contractual obligations.
· Foster a culture of collaboration by developing and maintaining strong and positive relationships with stakeholders both internally and externally.

· MS/BS degree in life science or related field required, advanced degree in business or life science (MBA or Ph.D.) is preferred.
· 5+ yrs relevant experience in biotech/life sciences business development, alliance management, corporate development, due diligence, financial analysis, market and competitive research/analysis, and strategic planning.
· Strong communication and influencing skills, cross-functional team leadership abilities, as well as a high level understanding of drug discovery and development process.
· Experience in working with or in large multi-national pharma preferable, not required.
· Possesses a unique blend of strategic thinking, exceptional product and market expertise, and an ability to thrive in a startup environment.

Ensem Therapeutics is seeking an Executive Administrative Assistant. The Executive Admin will report to the President and Chief Executive Officer. In this role you will provide a high quality, comprehensive, accurate and timely administrative service. This role has responsibility for all logistical and administrative functions to ensure a professional interface, seamless communication, and optimal coordination of activities on their behalf.

· Manage calendars of the President and CEO and designated team members as required - responsible for meticulous calendar management, including planning meetings, coordinating recurring events and communicating with multiple parties to schedule large scale internal/external meetings.
· Arrange domestic and global travel for the team, including preparing relevant documentation and itinerary packages in a timely manner, manage real-time travel issues as they arise and preparing expense reports.
· Provide fluid support across both corporate and personal calendars including travel and appointments.
· Coordinate small and large meetings and events, both on and off-site, in collaboration with administrative staff from other locations, both domestic and international, as appropriate.
· Prepare and manage documents, drafting, editing and proofing various types of documents, including - memos, correspondence and non-technical presentation materials.
· Support internal team in Board of Director preparation.
· Follow-up actionable items arise from meetings e.g., producing minutes and ensuring timely distribution of relevant documents.
· Prepare, submit and tracking expense reports for the team, as necessary.
· Directs office activities and functions to maintain efficiency including telephone services, email correspondence, mail distribution and all office management needs (supplies, stocking, upkeep).
· Support organizing social and fun activities including Company lunches, off-site activities, etc.
· Maintains records, documentation, and files.
· Performs other related duties as assigned.

· Bachelors degree in Business, Communications or related field.
· Minimum of four years of experience as an administrative or equivalent supporting senior level executives.
· Proven experience as an EA within a similar industry (BioPharma, Med-Tech, etc.).
· Prior experience working with remote, international teams in a globally matrixed organization.
· Ability to represent the company and President and CEO in a professional manner.
· Excellent verbal and written communication skills, organizational skills and attention to detail.
· Excellent time management skills with a proven ability to meet deadlines and flexibility.
· Strong proficiency in Microsoft Office (Outlook, Word, PPT, etc.) and Microsoft Teams. Experience with Concur Function with the highest integrity.
· Ability to function well in a high-paced and at times stressful environment.