Vice President, Cmc, Telavant

Telavant, a Roivant company, is a clinical-stage biotechnology company developing innovative therapies to treat inflammatory and fibrotic diseases. Telavant’s first investigational product, RVT-3101, is a fully human monoclonal antibody targeting TL1A. We are developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach.

To learn more about our company and pipeline, visit us at https://www.telavanttx.com/ .

About Roivant

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.

Position Summary

The Vice President, CMC will be a key member of the executive management team and an important leader for the company. The primary task is to fulfill the potential for the company’s lead project (RVT-3101) to successfully conduct Phase 3 clinical trials and commercialization of the product.

The VP, CMC will have primary responsibility to oversee manufacturing activities of Telavant’s lead asset from the Phase 3 clinical phase through commercialization. In addition, the VP of CMC will work closely with the project team (clinical, non-clinical, regulatory, quality, commercial) to develop CMC strategy, forecast drug substance and drug product needs, manage supply chain and logistics, and manage budgets. They will advise the Senior Management team on strategic CMC development.

The VP of CMC will lead process development and optimization activities to ensure a robust, scalable and cost-effective manufacturing process for drug substance and drug product. The VP of CMC will plan and lead activities for clinical manufacture and eventually for BLA file and launch. They will plan for process characterization and validation activities in preparation for BLA filing. Working with the VP of Combination Product Development, the VP of CMC will oversee the combination product strategy and development plan to allow for commercialization of both an autoinjector and syringe product. They will ensure manufacturing and analysis are performed in accordance with cGMP and FDA/EMA regulations.

Furthermore, the VP of CMC will be responsible for developing CMC regulatory strategy and authoring quality modules for regulatory files and represent CMC in interactions with regulatory agencies.

The VP of CMC will manage the supply chain for Telavant projects and lead packaging and labelling activities for clinical trial and commercial supply.

The VP of CMC will supervise and develop direct reports on the CMC team.

Candidate Profile

The successful candidate will be an experienced drug development scientist with a background as a Chemistry, Manufacturing and Controls expert in the biotechnology and/or pharmaceutical industry.

The successful candidate will likely have a mix of the following experience / education:

• Proven expertise and track-record of leadership of process and analytical development of biologics. Experience in setting CMC strategy, supply planning and budgeting.
• Strong communication and interpersonal skills including presentation capabilities and the ability to work effectively with peers, direct reports, other functional leads and the Company Board.
• Track record of authoring CMC sections of successful IND, CTA, NDA, and/or BLA submissions
• D (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field.
• Willingness to travel within US and EU
• 15+ years experience, in biologics drug development and manufacture
• Knowledge of cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions
• Must have demonstrated leadership experience in managing diverse project activities (upstream, downstream, drug product/formulation, combination product development, analytical, clinical supply) with contract CDMO facilities.

In terms of personal competencies required for the position, we would highlight the following:

Drug Development Experience

• Experience in developing CMC regulatory strategy and authoring CMC sections of regulatory submissions.
• Substantial biotech/industry drug development experience is necessary, a track record leading process development and product supply activities for biologics.
• Experience developing combination products such as autoinjector devices is desired.
• Demonstrated success in leading late phase CMC programs and proven track-record of developing robust manufacturing processes and managing clinical manufacture at external CDMOs. Experience in process characterization, process validation and commercial launch of biologics preferred.
• Proven track record of leading teams and delivering on excellence in planning and execution to timeline and budget.

Setting Strategy and Executing for Results

• Broadly skilled drug development scientist with evidence of strategic, tactical and operational abilities.
• Intellectual flexibility to lead a broad spectrum of activities with a “hands-on” approach and possessing a high level of comfort working within a fast-paced, entrepreneurial environment.
• Oversees and develops product supply strategy, taking into account scientific, regulatory, quality and commercial considerations.
• Demonstrates creativity and effectiveness in addressing strategic challenges.

Leading Teams

• Provides clear directions, delegates appropriately, communicate proactively, providing both project and people management skills.
• Demonstrated ability to manage a team in an entrepreneurial setting (i.e. non-hierarchical leadership and communication style) and with external parties (such as CDMOs).
• Proven track record of leading CMC activities for clinical stage development programs, motivating team members to work collaboratively to achieve objectives across functions.
• Can work effectively in a small organization.

Building Relationships and Using Influence

• Strong influencing skills both internally (towards team and board of directors) as well as externally with CDMO’s and Regulatory Authorities.
• Excellent communication, negotiation, interpersonal and intercultural skills.
• Personality that is creative, innovative, collaborative.

Telavant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.