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Roivant Sciences is global healthcare company focused on biomedical research.
 
New York City    Posted: Tuesday, January 29, 2019
 
   
 
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JOB DETAILS
 

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

Position Summary:

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:

  1. Developing & executing the clinical operations strategy;
  2. Collaborating with ACES cross-functional team to maintain & manage the existing integrated development plan against company goals; and
  3. 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

Responsibilities:

  • 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

Working Conditions:

  • Dynamic, interactive, fast-paced office environment
  • Limited domestic or international travel may be required

Compensation:

  • Competitive compensation & benefits package, including initial equity options grant
  • Equity options granted annually for top performers
 
 
 
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