Unique opportunity to join an exciting, mid-stage biotechnology company
Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris recently closed a $100M private financing from leading life sciences investors. We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients later in 2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.
Managerial and Strategic Responsibilities:
- Provide regulatory CMC strategic leadership to support development of cell therapy product in solid organ transplant and autoimmune diseases
- Develop high quality regulatory strategies and plans for health authority interactions to achieve optimal development objectives and life cycle management plans.
- Demonstrates high level of leadership and expert understanding of global of regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Lead CMC Regulatory product activities and timelines
- Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
- Lead interactions with regulatory consultants/advisors for strategic input and challenge.
- Communicate key program information to regulatory team members and Talaris management.
- Provide strategic input on key HA documents, obtaining appropriate line endorsement as appropriate.
- Provide strategic input, review and approve clinical study protocols and protocol amendmentsManages and/or mentors staff members, if required.
- In this capacity, you will develop regulatory strategies for the US andlead the preparation of regulatory submissions such as INDs, CTAs, annual reports, NDAs, MAAs and briefing packages. You will represent Regulatory Affairs in meetings with regulatory authorities, provide regulatory guidance to project teams, and write regulatory documents to support regulatory submissions. In addition, you will coordinate activities with external publishing resources and manage submissions activities with contract research organizations (CRO).
- Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes, and coordinate regulatory compliance activities at a global level.Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
- Drive adherence to CMC regulatory guidelines relevant for the development of cell therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
- Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures and pediatric investigation plans, and MAAs or BLAs are complete, well written, and meet all relevant requirements
- Partner and work very closely with Pharmaceutical Science, Quality, Nonclinical, Clinical and Regulatory project leads to ensure achievement of submission deadlines and obtain timely approvals of bluebird bio CMC related applications
- Lead regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to Talaris in-house CMC teams and Project/Product teams
- Manage and implement planning, preparation and submission of high-quality CMC related applications
- Effective matrix management. Where possible and to the extent possible, provide mentorship and opportunities for growth and development.
- Manage and develop talent, in a very collaborative environment
- Serve as role model embracing Talaris Values and Behaviors.
Health Authority Interactions:
- Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
- Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
- May lead interaction with HAs during key HA meetings
- Identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning.
- Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
Submissions and Approvals:
- Lead the global submission planning process, including potential Advisory Committees.
- Lead regulatory submission process throughout project lifecycle. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
- Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval.
- Reviews promotional and non-promotional materials and press releases as required and ensures messages are consistent with health authority guidelines.
Qualifications & Requirements
- Masters degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree, such as a PhD is desirable
- Minimum 10 years of relevant biopharmaceutical industry experience, with at least 10 years’ regulatory experience and
- Desired 4 years in CMC-focused Regulatory Affairs for biologics and direct interactions with regulatory health authorities and BL
- A/MAA filings, and ideally in an area related to cell or gene therapy
Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com
Talaris is an equal opportunity employer and prohibits unlawful discrimination.