Senior Manager, Clinical Supply Operations

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

RESPONSIBILITIES:

  • Oversee and maintains clinical supply plans for overall study demand, expiries, and product cycle times by asset.
  • Ensures that key project milestones are met; negotiates and communicates clinical supply plan timelines to internal and external stakeholders and partners.
  • Manages direct outsourcing of packaging, labeling (including creation, translations, and label approval) for on-time distribution of drug supply to global sites.
  • Accountable for generation of packaging requests, review and approval of pre-production and post-production documentation. Coordinate with QA for release of clinical supplies
  • Communicates and prioritizes and/or escalates clinical supply issues through the established pathways both internally and externally.
  • Participate in Clinical Study Team(s) and define clinical supply needs based on protocol(s), information gathering and serve as representative for clinical supply operations function.
  • Participate in CMC cross functional team to communicate clinical supply demands and timing and gain overall program supply plans to understand risks and inform effective decision making.
  • Contribute to supply scenarios to provide clinical supply options to meet clinical plans and implement endorsed strategies.
  • Provide real time input into demand plans to ensure supply and demand are aligned and kept current to evolving assumptions.
  • Integrate cross-functionally to ensure quality project execution.
  • Work with group to propose, develop, implement, and monitor Clinical Supply Chain and personal goals.
  • Regularly meet with manager to report challenges and risks and propose resolutions.

 

EDUCATION AND EXPERIENCE: 

  • Bachelor’s degree required. 
  • Industry professional with 5-7 years combined experience in functional area (e.g. packaging, logistics) or related field.
  • Thorough understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GxPs governing the manufacture of pharmaceutical drug and conduct of clinical trials in a regulated environment.
  • Advanced knowledge of labeling, packaging, inventory management and distribution procedures related to clinical supplies.
  • Direct experience working with Interactive Response Technology (IRT) system(s) including creation and oversight of IRT system development aspects such as system specifications, user acceptance testing and system management during study conduct.
  • Flexibility and ability to react promptly to multiple short-term deadlines and manage competing priorities in a fast-paced and dynamic environment.
  • Experience working with clinical packaging vendors/external partnerships and relations.
  • Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment.
  • Proven problem solving, decision-making skills, ability to work with a high level of integrity, accuracy, and attention to detail.
  • Demonstrated ability to manage multiple projects / tasks independently and effectively.
  • General knowledge of business-related areas: project management, contracts, invoicing, and finance
  • Excellent interpersonal, influencing and negotiation skills.