Senior Director, Clinical Development, Infectious Disease - Bethesda, United States - Moderna

Description

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Senior Director, Clinical Development, Infectious Disease
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locations
Bethesda, Maryland
Clinical Development
time type
Full time
posted on
Posted 5 Days Ago
job requisition id
R13525

The Role:

Moderna is seeking a physician to lead a Phase 3 clinical development program for one or more of their development programs in Infectious Diseases.

Board certification in Infectious Diseases, Internal Medicine and/or Geriatrics, or Obstetrics and Gynecology is desirable. At least 5 years of research and industry experience in vaccine development is highly desirable.
This role will report to Modernas Therapeutic Area Head, Clinical Development, Respiratory Virus Vaccines and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review and interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external
partners.
The position is based at Modernas Cambridge, MA, Princeton, NJ or Bethesda, MD sites.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines.

Excellence in communication, teamwork, and collaboration is a must.

Heres What Youll Do:
Provide clinical scientific leadership to the blinded Phase 3 clinical trial team.
Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
Either directly monitor or provide medical safety oversight of CRO medical monitors.
Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.

Collaborate closely with partners in the Clinical Operations, and be accountable for clinical trial conduct and timelines for associated key deliverables.

Lead the design and writing of clinical protocols and associated clinical documents.

Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.

Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
Contribute to the writing of manuscripts and publications.
Comply with Moderna SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
Provide medical leadership for internal audits and regulatory inspections.
Assist in preparations of materials for Advisory Board meetings.
Develop and maintain strong, collaborative relationships with the broader Moderna organization.
Represent Moderna externally to trial site Investigators and administrators.

Heres What Youll Bring to the Table:
MD or non-US equivalent of MD degree with completion of residency in Internal Medicine, Family Practice, or
Obstetrics/Gynecology.
Completion of a fellowship or focused training in Infectious Diseases or Geriatrics is desirable.
Minimum 5 years experience in early- to late-stage development in an academic or industry setting


Proven ability to:
Plan and conduct clinical trials
Deliver high-quality results within established timelines
Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
Experience on a previous Phase 3 development program is highly desirable
Ability to thrive in a fast-paced environment.

Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

Excellent analytical, problem-solving and strategic planning skills.
Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
Exceptional written and oral communication skills to meet the needs of varied audiences.
Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.
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
D iscretionary 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

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
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at

(EEO/AAP Employer)
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About Us
Our Mission and Vision
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 bodys 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 will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.

Please inform the company's personnel representative by calling or emailing

if you need assistance completing any forms or to otherwise participate in the application process.

Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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