Project Manager, Medical Affairs Job at Sarepta Therapeutics
The Associate Manager, Medical Affairs provides project management support related to launch preparedness for a late-stage gene therapy asset in Duchenne muscular dystrophy as well as activities related to OUS (outside US) functions for the Medical Affairs organization. This role supports senior leaders in planning, tracking, and execution of Medical Affairs initiatives aimed at ensuring internal systems are created and appropriate resources can be deployed to deliver Sarepta’s gene therapy portfolio safely and effectively to patients at the time of commercial approvals. The Associate Manager will manage the integrated US Medical Affairs launch plan, facilitate key launch and OUS work stream meetings, and contribute to all phases of project execution. This individual will work across functions to ensure accountability and alignment, leveraging strong project management capabilities and the ability to manage complex work streams in a dynamic cross-functional environment. This position resides within Medical Affairs and reports to the Executive Director Medical Affairs, Medical Launch Lead & Global Strategic Engagement.
Primary Responsibilities Include:
- Lead project management support reporting to the Executive Director Medical Affairs, Medical Launch Lead & Global Strategic Engagement, and team members
- Accountable for project management and active engagement in the planning, tracking, development, and execution of various gene therapy launch related activities
- Manage the Medical Affairs launch budget, OUS budget and provide financial reporting to senior leaders, including managing contract requests and purchase orders/invoices
- Provide tactical oversight while managing and collaborating with external vendors, partners, and consultants on various launch related efforts
- Work cross functionally to ensure the Medical Affairs launch timelines and goals are met
- Work cross functionally to ensure the OUS Medical Affairs timelines and goals are met
- Create, maintain, and update dashboard to track launch readiness key performance indicators
- Create, maintain, and update dashboard to track OUS Medical Affairs key performance indicators
- Ensure clear communication of gene therapy launch status and timelines, providing relevant and timely updates the Medical Affairs team and key cross-functional partners, as appropriate
- Proactively identify issues and partner with senior leaders to develop contingency plans for highest risk / highest probability issues to enable the team to effectively mitigate risks
- Effectively manage meetings including the development, management, and facilitation of strategically focused agendas and meetings, as well as taking concise meeting minutes and capturing and following up on action items in a timely manner
- Other related duties as needed
- 60% of time spent on OUS activities and 40% of time spend on SRP-9001 Launch activities
Desired Education and Skills:
- Bachelor’s Degree required with at least 3-4 years of applicable experience within clinical/health care, pharmaceutical industry, project management or related field
- Experience executing against strategic plans and vendor management
- Knowledge of gene therapy space or experience in launching gene therapy preferred
- Proven track record of proactive problem solving and strong tactical execution
- Excellent organizational, interpersonal, and verbal/written communications
- Ability to succeed in an ambiguous environment
- Strong ability to build partnerships across functions
- Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: Bias to Action, Patients First, Talent, Integrity, and Unconventional Thinking
- Ability to travel into the Cambridge office as needed
- Ability to travel international as needed for planning meetings related to OUS mtgs
This position requires work on site at one of Sarepta’s facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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