- This position works with the SVP of Medical Affairs and MA/SA functional leads to develop the overarching strategy, ensuring aligned execution plans.
- Coordinates the development of the Medical and Scientific Plan globally.
- Provide decision analysis expertise and tools to the project leads in strategic planning and operational execution, ensures timely and well-informed decision-making.
- Operational Program Management by ensuring Medical and Scientific Affairs initiatives and tactics are executed within agreed upon timeline and budget.
- Drives cross functional project team and deliverable team effectiveness.
- Organize and facilitate the monthly Medical/Scientific Affairs group calls by therapeutic area and all team meetings with functional leads.
- Organize and facilitate executive level Medical and Scientific presentations to executive leadership team and Board of Directors (BOD).
- Manage and oversee congress related activities such as session planning, KOL engagement, advocacy engagement, pre and post congress debriefs, daily debriefs, congress summary and educational and scientific booth activities.
- Supervise the grants review process including overseeing the requests, lead the monthly committee meeting, and facilitating the communication with the grant requestors.
- Works with/supports the SVP of Medical Affairs on all medical affairs related activities, as well as with the Mirum leadership team (providing project tracker or status updates as needed).
- Supports cross-functional partners on various tactics (e.g. Brand Plan, National Sales Meetings and commercial materials).
- Liaise with other departments with regard to Medical/Scientific Affairs tactics, plans and assist with projects (Commercial, Corporate Communications, Clinical team, Accounting/Finance, and Human Resources).
- Actively respond to project risks, mitigate, prevent and/or resolve potential risks or issues.
- Manage the cross functional project team operational activities to ensure milestones and goals are met.
- Bachelor's, Master's, or Doctorate (i.e. RN, BS/BA, MBA, MS/MA, PharmD) level of degree from an accredited university/program.
- Individuals with project management and operations experience are preferred.
- 5+ years of biopharmaceutical experience, with an understanding of the current regulatory and compliance environment for prelaunch and postlaunch initiatives for an investigational asset.
- Proficient in Microsoft OneNote, Office 365 (proficiency with Microsoft TEAMS, PowerPoint and Excel are essential skills).
- Highly organized individual, who possesses the ability to work in a fast-paced, agile environment.
- Ability to interact externally and internally to support global business strategy across assets and launches.
- Must possess excellent oral and written communication skills.
- Ability to interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, clinical development, statistics, regulatory, publications, as they relate to on-going medical affairs projects.
- Represents Mirum at external meetings including investigator meetings, scientific congresses, regulatory meetings, along with advisory boards etc.
- Ability to work independently with some supervision and guidance.
- Exercises sound judgment within well-defined practices and policies.
- Ability to manage budget for assigned projects.
- Familiar with ICJME authorship criteria.
- Clinical experience/research background or knowledge in one of following areas: liver diseases, pediatrics/neonatal care, cholestasis or rare diseases is preferred.
- Ability to travel 25% of the time.
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Director, Medical Affairs Operations - Foster City, United States - Mirum Pharmaceuticals Inc
Description
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities.
Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases.
We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values:care, be real, get it done, and have fun, seriously.
Learn more about our work, our culture, and what it's like to be a part of our team:
POSITION SUMMARY
The Director works with the Medical and Scientific Affairs leadership team to develop and organize the product(s) strategy; ensuring aligned execution plans; and drives the execution of the strategy and key tactics.
Superior team management skills and ability to develop clear and concise communication to a wide range of stakeholders (product and cross-functional teams, functional leadership, Governance Boards (Board of Directors) collaborators, and development partners) is required.
JOB FUNCTIONS/RESPONSIBILITIESQUALIFICATIONS
Education/Experience:
Knowledge, Skills and Abilities:
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
