- Lead the DMPK team in alignment with the corporate mindsets, to execute on Moderna's ambitious and dynamic agenda to deliver transformational medicines and vaccines to patients.
- In conjunction with development program teams and a cross-functional and integrated nonclinical drug development sciences team, provide strategic oversight on and coach/guide team members on the development of scientifically-sound ADME/PK/PD and drug-drug interaction (DDI) risk assessment strategies to provide expert support to discovery and development projects.
- Accountable for the design, execute, and critical analysis of nonclinical in vitro and/or in vivo studies conducted in multiple species via collaborative partnerships with study monitors and other partner line program representatives (e.g., toxicology, bioanalytical, operations, etc.).
- Collaborate closely with and establish positive working relationships with leaders of/colleagues from other nonclinical disciplines (e.g., toxicology, bioanalytical, pharmacology research, study management & outsourcing, writing, strategic operations) to deliver on integrated nonclinical data packages for programs and also with pharmacometrics PK/PD modeling modelers to define the PK/PD studies and data needed to establish PK/PD correlations and support first-in-human dose projections.
- Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/regulatory strategy.
- Review, edit, and/or author regulatory submissions and health authority interaction documents (e.g., briefing documents, regulatory query responses) and integrate results with toxicology and pharmacology.
- Regularly operate as a leader for DMPK program representatives both formally (having direct reports) and within a matrixed structure informally by providing scientific guidance and input and by leading by example.
- Manage the preparation and presentation of ADME/PK/PD/DDI data for project teams, portfolio management, internal/external partners and/or scientific groups.
- Maintain extensive scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large.
- In addition to serving as Head of the DMPK line function, the incumbent will also serve as an independent contributor for a select number of discovery and/or development programs as a DMPK representative. Heres What Youll Need (Minimum Qualifications)
- PhD & 12 years of scientific experience OR Masters degree & 17 years of scientific experience OR Bachelors degree & 25 years of scientific experience in preclinical ADME/PK/PD and drug development in the pharmaceutical/biotechnology sector.
- Experience serving in the capacity of a DMPK representative on drug development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical ADME/PK/PD/DDI strategies and studies to support clinical development.
- Experience in mentoring, coaching, and managing others on developing ADME/PK/PD/DDI strategies.
- Direct experience in writing and reviewing nonclinical sections of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs, briefing documents, regulatory query responses).
- Familiarity with regulatory guidelines for the conduct of ADME/PK/PD/DDI studies to support regulatory filings.
- Experience working with Contract Research Organizations.
- Experience with and a passion for people management, team building, and creative solution seeking.
- Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders. Heres What Youll Bring to the Table (Preferred Qualifications)
- Attention to detail and quality, and ability to deliver work on time.
- Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions.
- Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.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, theinfrastructure 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 peopleare 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 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. Were 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 (EEO/AAP Employer)#LI-JW2
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Sr. Director, DMPK - Cambridge, United States - Moderna, Inc.
Description
The Role
At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individuals contribution is vital.
In this role, you will serve as the Head of the Drug Metabolism and Pharmacokinetic (DMPK) line function. You will apply your people management and subject matter expertise in absorption, distribution, metabolism, and excretion (ADME), pharmacokinetics (PK), and pharmacodynamics (PD) to drive program strategies and define new scientific directions of the department with leadership. Superior communication skills, a strong record of employing creativity to achieve meaningful outcomes in drug development, and comfort working in a dynamic, fast-paced, cross-functional team environment are required.
Heres What Youll Do
Sr. Director, DMPK professionals in Cambridge
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Brian Sodano
Build Engineering Teams, Products, and Platforms.