Director, Program Leader, Preclinical Development

Posted 20 Days Ago
Be an Early Applicant
2 Locations
Senior level
Healthtech • Biotech
The Role
The Director of Preclinical Development will define and manage the strategy for preclinical programs, particularly for rare diseases and immune therapeutics. This role involves leading cross-functional teams, guiding regulatory submissions, and ensuring comprehensive evaluations of drug candidates for safety and efficacy. A strong background in gene editing and experience in IND filing are critical, alongside project leadership and communication skills.
Summary Generated by Built In

The Role:

We seek a talented, experienced and motivated Director for the Preclinical Program Lead role supporting the Rare Disease and Immune Therapeutic Research therapeutic areas.  The Preclinical Program Lead will be responsible for defining the overall strategy for the development of the preclinical program, aligning with the company’s business objectives, to support the advancement of Moderna’s mRNA technology platform and pipeline. The successful candidate will lead a cross-functional team and will be responsible for setting the strategic direction for preclinical studies, ensuring that a drug candidate is comprehensively evaluated for safety and efficacy to support IND submission and enable clinical evaluation. The Preclinical Program Lead will report progress and findings to senior management, scientific advisory boards, and cross-functional teams, providing updates on the project status, risks, and go/no-go decisions. Experience in gene editing is required, additional experience in Immunology would be a plus.

Applicants should be outstanding team members and have extensive experience in project leadership.  The ability to effectively communicate across internal multi-disciplinary teams and with external partners is required.  The candidate will need to manage multiple projects in a fast-moving and results-oriented environment.  Experience in IND filing is required as the candidate will facilitate programs moving into Development.

Here's What You’ll Do:

  • Manage multiple projects of moderate to large size and scope involving cross-functional collaboration within Research and across departments. Provide scientific expertise, guidance and strategy to successfully drive programs through Go/No Go decisions.

  • Lead a cross-functional team to develop, optimize, validate and execute preclinical studies to support IND submission

  • Support programs through IND filing collaborating with multiple functions within Moderna, working closely with clinical development teams to ensure a smooth transition and transfer of program data and leadership to enable Phase I clinical trials.

  • Author and review regulatory documents

  • Communicate effectively to discuss project progress, interpret and present data internally and externally.

  • Provide expert level guidance in designing and implementing cell biology, biochemistry and biomarker related studies for rare and/or autoimmune diseases.

  • Ability to manage and supervise team members to meet project timelines

  • Support scientific engagement with external collaborations. Act as a scientific resource providing guidance and mentorship to colleagues.

Here’s What You’ll Bring to the Table:

  • A B.S/M.S degree in Genetics, Biochemistry, Molecular Biology, Cell Biology, Immunology, or related field with 12 years of overall experience in drug discovery and development or a Ph.D. with 9+ years of experience specifically in drug discovery in pharmaceutical, biotech or CRO

  • Solid background and training in Gene Editing and/or Immunology

  • Experience in autoimmune diseases

  • Managerial capabilities such as strategic thinking, decision-making, problem-solving, communication, and delegation, good knowledge and experience in Gene Editing research and biologics, and track record of making contributions to advance therapeutics from concept to proof-of concept in-vivo into a clinical candidate

  • Familiarity with disease biomarkers

  • Experience in drug discovery or translational research in a biotech setting

  • Experience in IND filing required

  • This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

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 year-end shutdown
    •    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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected].  (EEO/AAP Employer) 

#LI-KH1

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Top Skills

Autoimmune Diseases
Biochemistry
Biomarker Studies
Cell Biology
Drug Development
Gene Editing
Immunology
Ind Filing
Mrna Technology
Project Leadership
Rare Diseases
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The Company
Cambridge, Massachusetts
6,848 Employees
On-site Workplace
Year Founded: 2010

What We Do

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.”

Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.

Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured.

To learn more, visit www.modernatx.com.

This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).

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