Roivant Sciences mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. The company is privately held, has in-licensed 25+ assets, & is very well-capitalized. The ACES team (Accelerated Clinical Evaluation & Strategy) works together with the Roivant Investments Team to establish the scientific & business rationale for novel in-licensing opportunities & is accountable for creating the initial development strategy for acquired assets.
Position Title: Director, Project Management & Clinical Operations, ACES Team (Accelerated Clinical Evaluation & Strategy)
Position Location: New York, NY
Manager Title:Head of Project Management & Clinical Operations, Roivant Pharma
This is a highly visible key role which offers a unique opportunity to act as Project Manager & Clinical Operations lead in the launch of newly created biotech/pharma companies across a diverse portfolio of indications & therapies.
From the acquisition of a new pharmaceutical asset until the transition of that asset to a newly created Vant: subsidiary company, this position will have three primary responsibilities:
- Developing & executing the clinical operations strategy;
- Collaborating with ACES cross-functional team to maintain & manage the existing integrated development plan against company goals; and
- Providing project management support as needed for the integrated development plan of new assets.
This position will also partner with the Head of Project Management & Clinical Operations to streamline processes & develop SOPs which may be leveraged across all Vant subsidiary companies
- Responsible for clinical operations strategy, initiation & execution of clinical trials, including (but not limited to) CRO selection, contracts & budgets, CRO oversight, & proactive risk management to ensure the quality conduct of trials with a high level of data integrity.
- Contribute as required to the authoring of key regulatory documents (e.g., CTD, pre-meeting materials & briefing packages), study protocols, investigators brochures, IND reports, study postings, etc.
- Collaborate with ACES team after new assets have been acquired to update & manage the integrated development plans to deliver against company goals.
- Author & execute the transition plan from the ACES team to the newly formed Vant for clinical operations & project management.
- Project management of initiatives as required, including both the identification of process improvements as well as contributing to & leading the development of SOPs.
Skills, Qualifications & Requirements:
- Bachelor's Degree in a scientific or technical discipline (Masters degree preferred)
- PMP Certification strongly preferred
- 5-10 years pharmaceutical or CRO industry experience with early, mid, & late-stage clinical development & regulatory submissions
- Strong understanding of relevant laws & policies guiding the biopharmaceutical industry, including FDA regulations, European Directive, & ICH/GCP guidelines
- Experience in building infrastructure (including SOPs) required
- Proven ability to build strong relationships with external partners, CROs, & vendors, including extensive experience managing contracts & clinical finance activities
- Demonstrated experience with MS Project, SharePoint, Office Timeline/OnePager or similar software systems/platforms
- Ability to work independently & collaboratively in a fast-paced, matrixed team environment consisting of internal & external team members
- Analytical thinker with excellent problem-solving skills & the ability to adapt to changing priorities & deadlines
- Excellent planning, organization & time management skills including the ability to support & prioritize multiple projects
- Dynamic, interactive, fast-paced office environment
- Limited domestic or international travel may be required
- Competitive compensation & benefits package, including initial equity options grant
- Equity options granted annually for top performers