Director, Medical Affairs Operations

2 weeks ago

Foster City, United States Mirum Pharmaceuticals Inc Full time

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: www.mirumpharma.com.

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. This position is the operational leader of the project or deliverable team. This position requires a firm foundation of experience in medical/scientific affairs operations. Moreover, a thorough understanding and effective application of project management leadership skills and techniques is required. 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/RESPONSIBILITIES

* 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.

QUALIFICATIONS

Education/Experience:

* 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.

Knowledge, Skills and Abilities:

* 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.

#LI-Onsite

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.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

  • Associate Director, Medical Affairs

    4 weeks ago

    Jersey City, United States Mitsubishi Tanabe Pharma Full time

    Overview: **Entrepreneurial Spirit, Rooted in Tradition**. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has...

  • Executive Director, Medical Affairs

    2 weeks ago

    Oklahoma City, United States Morphic Therapeutic Full time

    Description About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...

  • Director, Business

    4 weeks ago

    Culver City, United States Sony Pictures Entertainment, Inc Full time

    Sony Pictures Television Game Shows Division is seeking a Director of Business & Legal Affairs. The Director will be a key member of a multifaceted team that develops, produces, markets/promotes, and licenses game shows and related consumer products for any SPE game shows. Reporting to the SVP, the Director’s primary role will be to develop and build deal...

  • NO C2C

    1 day ago

    Foster City, United States Milestone Technologies, Inc. Full time

    NO C2C, NO 3rd parties, NO relocation candidates consideredSr Director of Medical Safety (Operations)Location: Foster City, CA. (requires on-site time) MUST BE LOCAL CANDIDATES - relocation candidates will not be consideredContract length: 6 months to start - possibility of contract to hire.Compensation:The estimated pay range for this position is $120/Hr. -...

  • NO C2C

    4 weeks ago

    Foster City, United States Milestone Technologies, Inc. Full time

    NO C2C, NO 3rd parties, NO relocation candidates consideredSr Director of Medical Safety (Operations)Location: Foster City, CA. (requires on-site time) MUST BE LOCAL CANDIDATES - relocation candidates will not be consideredContract length: 6 months to start - possibility of contract to hire.Compensation:The estimated pay range for this position is $120/Hr. -...

  • Director of Operations

    1 day ago

    Redwood City, United States HealthCare Recruiters International Full time

    Director of Operations (Medical Device)The Client:Our client is well-funded biomedical platform company aiming to deliver life-changing solutions to patients and their doctors. They design and develop state of the art Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.The Role:This Director or Sr. Manager of...

  • Director of Operations

    20 hours ago

    Redwood City, United States HealthCare Recruiters International Full time

    Director of Operations (Medical Device)The Client:Our client is well-funded biomedical platform company aiming to deliver life-changing solutions to patients and their doctors. They design and develop state of the art Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.The Role:This Director or Sr. Manager of...

  • Assistant Athletics Director for Internal Affairs

    6 days ago

    Oklahoma City, United States Oklahoma City University Full time

    Assistant Athletics Director for Internal AffairsMain Campus, Oklahoma City, Oklahoma, United StatesAthleticsRegular Full-Time Staff VP Area: Athletics Department: Athletics FLSA Status: Exempt Benefit Eligibility: Yes Position Summary: The Assistant Athletics Director for Internal Affairs is responsible for the day-to-day business affairs of the...

  • Assistant Athletics Director for Internal Affairs

    1 week ago

    Oklahoma City, Oklahoma, United States Oklahoma City University Full time

    Assistant Athletics Director for Internal AffairsMain Campus, Oklahoma City, Oklahoma, United StatesAthleticsRegular Full-Time StaffVP Area: AthleticsDepartment: AthleticsFLSA Status: ExemptBenefit Eligibility: YesPosition Summary:The Assistant Athletics Director for Internal Affairs is responsible for the day-to-day business affairs of the department,...

  • Director, Business

    3 weeks ago

    Culver City, United States Entertainment Services Alliance, Inc. Full time

    Sony Pictures Television Game Shows Division is seeking a Director of Business & Legal Affairs. The Director will be a key member of a multifaceted team that develops, produces, markets/promotes, and licenses game shows and related consumer products for any SPE game shows. Reporting to the SVP, the Director’s primary role will be to develop and build deal...

  • Senior Medical Director

    2 weeks ago

    Foster City, United States Mirum Pharmaceuticals Inc Full time

    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...

  • Associate Director Regulatory Affairs Ad Promo

    7 days ago

    Oklahoma City, United States EPM Scientific Full time

    Title: Associate Director, Regulatory Affairs Advertising & Promotion The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products...

  • Assistant Athletics Director for Internal Affairs

    2 weeks ago

    Oklahoma City, United States Oklahoma City University Full time

    VP Area: Athletics Department: Athletics FLSA Status: Exempt Benefit Eligibility: Yes Position Summary: The Assistant Athletics Director for Internal Affairs is responsible for the day-to-day business affairs of the department, facility management and competition operations, and supervision of assigned staff. The individual may serve as the Senior Woman...

  • Medical Director, Oncology, US Medical Leader

    3 weeks ago

    Charles City, United States TANNER & ASSOC INC Full time

    Medical Director, Oncology, US Medical Leader The US Medical Organization, Medical Director, Oncology, US Medical Leader is the single point of accountability and matrix leader for US Medical strategies, including US launch and life cycle management. The USML is responsible for: Leading the development, execution and communication of the US Medical Team...

  • Director Regulatory Affairs-CMC

    2 weeks ago

    Oklahoma City, United States Disc Medicine Full time

    Disc Medicine is seeking a Director, Regulatory Affairs-CMC to serve as the Regulatory-CMC lead for Disc Medicine’s small molecule program pipeline. This position will have close collaboration with the development teams and visibility to the executive leadership with meaningful opportunities for professional development and career growth.The position...

  • Government Affairs Manager

    7 days ago

    City of Industry, United States Athens Services Full time

    The Government Affairs Manager will report to the Vice President of Government Affairs and will support the Director of Government Affairs in the Athens West cities serviced out of the Los Angeles North (LANO) office. In this position, the successful Government, Manager, Vice President, Airline, Business

  • Lab Operation Lead/ Director

    4 weeks ago

    Foster City, United States HCLTech Full time

    Position - Lab Operation Lead/ Director Type - Full Time Location - Onsite in Foster City, CA Mandatory Skill- Lab Operations and Managing LIS team size 100+ Job Description - Responsible for maintaining the laboratories as a safe, functional, and compliant environment. Coordinate with external instrument/equipment vendors and facilities for installation...

  • Intern - Regulatory Affairs

    1 week ago

    Foster City, United States Mirum Pharmaceuticals Full time

    If you are not local to the Foster City area, are you willing to relocate? * Yes No I am local Are you currently authorized to work for any employer in the US without visa support? * -- By participating in job interviews, you agree to treat all information shared regarding Mirum’s commercial performance, clinical and scientific data, sensitive corporate...

  • Director, Strategy and Operations, Device

    4 weeks ago

    Foster City, United States Gilead Sciences Full time

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies...

  • Director of Legal Affairs

    6 days ago

    Jersey City, United States Cyera Full time

    Description Come join the company reinventing data security, empowering businesses to realize the full potential of their data. As the leading data security platform purpose-built for the cloud era, Cyera's mission is to reinvent how businesses secure data, enable agile collaboration, and boldly pursue new business opportunities. Trusted by security teams...