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Sr. Manager, Clinical Biomarker Program Specialist

Company: Moderna Therapeutics
Location: Cambridge
Posted on: May 14, 2022

Job Description:

Sr. Manager, Clinical Biomarker Program Specialist The Senior Manager of the Biomarker Program Specialist team will be responsible the management of vendors involved in clinical stage program bioanalytical analysis across Moderna's portfolio. The successful candidate will work closely with Program Specialists, Biomarker Leads, Finance and other stakeholders to ensure that critical timelines are met by our bioanalytical vendors and that those timelines accurately capture any program or study level changes. This position will communicate across multiple clinical teams, senior leadership and vendors. The initial focus of the group will be in the Infectious Disease therapeutic area, but will rapidly expand across all of Moderna's pipeline. The ideal candidate will have program management, bioanalytical assay development, and vendor oversight experience, preferably with late stage clinical programs. Here's What You'll Do: Work with the Biomarker Program Specialist group, focused on the oversight of timelines and delivery of bioanalytical data from vendors Become a point of contact for vendor engagements and responsible for those engagements Manage multiple vendors for high priority programs across the entire Moderna pipeline Understand and participate in the strategic selection of key external partners for bioanalytical assessment Maintain and grow partnerships with key external vendors across multiple bioanalytical areas, including immune, genetic and flow cytometry assays Implement and/or optimize core Program Management tools/processes for reporting, tracking, data collection, synthesis, budgets, integration, scenario-planning, risk and stakeholder management. Be a thought partner to the Biomarker leads to problem-solve, aid in implementing strategies that drive maximum potential realization, and shape the direction of the program. Drive effective decision-making at the Program and senior leadership level through: Engagement with key stakeholders, including clinical teams, data management, statistics and finance leads Proactively identifying and escalating gaps and challenges along with potential solutions Manage the biomarker program analyst team through challenging timelines and prioritizations Proactive communication that is outcome and solution-driven Have visibility, bandwidth, and influence to drive completion of all deliverables and key responsibilities, building and leveraging relationships with key stakeholders (team members and leadership) and organizational dynamics to promote program goals. Work with the Finance group to implement and track program budget and find/suggest trade-offs as needed. Here's What You'll Bring to the Table: Graduate degree with 5+ years of experience in a biotechnology or pharmaceutical setting or Bachelors degree with 10+ years of experience Project/program management training or certification preferred Bioanalytical or CRO experience Experience with infectious disease/vaccine development is preferred Generally subject matter expertise in late-stage drug development across Phase 1-3, submission, post marketing (i.e., Phase 4) and lifecycle development (end to end R&D). Core Program Management strengths with tools and best practices for reporting, tracking, data collection, synthesis, budgets, integration, scenario-planning, risk and stakeholder management. Demonstrated high-level cross-functional leadership and integration across large complex Programs and assuring alignment with Program leadership, stakeholders, and enterprise priorities. Strong track-record in implementing strategies that drive maximum potential realization Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally. Strong personal skills to influence without authority, motivate others and manage conflict. Strong written and oral communication skills as well as demonstrated organizational -aptitude Preferred: Project/program management training or certification Preferred: Experience with infectious disease/vaccine development. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes -
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    --- Vacation, sick time and holidays
    --- Volunteer time to participate within your community
    --- Discretionary winter shut down -
    --- Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About Moderna In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com . Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-MC1 At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna is committed to providing access to employment opportunities to all qualified individuals with disabilities, including disabled veterans. -Reasonable accommodation is a modification or adjustment to a job, the work environment, or the way things are usually done during the hiring process. These modifications enable a qualified individual with a disability to have an equal opportunity not only to get a job, but successfully perform their job tasks to the same extent as people without disabilities. - Consistent with our non-discrimination and accommodation policies, any applicant who needs an accommodation in connection with the hiring process or to perform the essential functions of the position for which the applicant has applied may make a request for accommodation to the recruiter or receive further information by calling +1-617-460-9346 or emailing humanresources@modernatx.com . This contact is intended for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process or technical assistance. The Reasonable Accommodation Process, following the guidelines established by the ADAAA, is a collaborative and interactive process between the applicant or employee, Human Resources, the manager, and/or subject matter experts.

Keywords: Moderna Therapeutics, Cambridge , Sr. Manager, Clinical Biomarker Program Specialist, Healthcare , Cambridge, Massachusetts

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