Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
What would it be like?
This role will be responsible for elevating the Program Leadership/Project Management and Alliance Management functions to ensure creation of the program plans and budgets, as well as day-to-day planning, coordinating and tracking of critical activities. You will be responsible for providing critical Program/Project Management expertise and support to Turnstone Biologics internal programs and strategic partnerships to ensure all Program / Project milestones and deliverables are met, and that tasks are well managed and executed. You will also be responsible for driving the program timelines to keep them on schedule and within budget. Additional coordination responsibilities, as highlighted in more detail below, also include planning, facilitating, and following-up on regular program team meetings; anticipating and managing potential program issues; understanding the scope, schedule and resources for the program; utilization of Gantt charts and other project management tools to facilitate communication within the team, across the organization, and with external collaborators. RESPONSIBILITIES · Oversee internal program leadership, project management and alliance management · Partner with the Program Leaders, project and alliance managers to optimize team effectiveness and decision making · Coordinate the management of internal and external programs including project planning, progress tracking and budget planning & tracking · Interface internally by acting as a liaison and facilitator of cross functional teams (i.e., Clinical Development, Clinical Operations, Technical Operations, Regulatory, Quality Assurance, Finance, etc.) in planning and executing trials · Champion the development of the Program Leadership Department through introduction of new tools and processes for continuous improvement · Sets key performance indicators and create timelines for driving internal and external programs on schedule. · Facilitate highly effective team building and communication · Proactively and independently, identifies and resolves program team challenges · Perform effective risk management assessments with the Program Team, the Program Leader, and stakeholders · Drive information flow and communicates program status to all stakeholders in collaboration with the Program Leaders and Project Managers.
· Coordinate production of regular status reports (milestones, status, issues, decisions), following review by the Program Leader and Program Team, for executive and senior management · Coordinate portfolio reviews · Support program knowledge management and data integrity procedures · Partner with business development to initiate strategic relationships · Manage and optimize the value of our strategic alliances across research, development and clinical
· Function as the internal and external point of contact for collaboration management and progress · Support sponsored research contract execution · Interface externally with collaborators, vendors, contractors, and consultants to ensure communication and deliverables in accordance with planned program objectives · Identify platform, program and product issues · Support regulatory filings
· Support setting of program strategy · Support corporate financing initiatives · Mentor and develops program leadership & management group members QUALIFICATIONS AND REQUIREMENTS: · Minimum of a BA/BS is required, while an advanced degree (PharmD, PhD) is highly desirable.
· 10+ years of work experience, 8-10 years of Program/Project or Alliance Management experience, preferably within a matrixed pharmaceutical, biotechnology or medical device organization · Extensive project planning experience required, especially an understanding of the clinical development and product commercialization processes. PM Certification is a plus · Oncology experience is highly desirable.
· Advanced (gene or cell) therapy experience is highly desirable.
· Proactive mindset with strong formal and informal leadership, facilitation, teamwork and influence management/negotiation skills. · Must have excellent verbal and written communication skills as well as exceptional organizational capability.
· Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
· Ability to drive program plans and timelines (across multiple functional areas) is essential
· Proven success in goal setting, prioritization and time management is required
· Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired
· Experience working with external partners is highly desirable
· Experience actively participating in a steering committee or joint development committee for pharmaceutical, biotech, or medical device product development is highly desired · Ability to work independently in decision-making and resolution of program obstacles and conflicts
· Familiarity with developing budgets and forecasting is desirable · Keen insight, independent judgment and tactful discretion are required · Must be able to demonstrate strong analytical and problem-solving capabilities
· Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture” · Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.