Current jobs related to Clinical Development Director - Cambridge, Massachusetts - Moderna Therapeutics

  • Senior Medical Director, Clinical Development, Head of Movement Disorders

    4 weeks ago

    Cambridge, Massachusetts, United States Biogen Idec Full time

    About This RoleAs a pivotal leader within Biogen, the Senior Medical Director, Clinical Development and Movement Disorders Lead will spearhead clinical development strategies and provide medical expertise across our movement disorders portfolio, including business development with a focus on the future portfolio. This role is situated within the Therapeutics...

  • Clinical Trials Director

    4 weeks ago

    Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Director to lead the planning, implementation, and execution of global clinical trials. As a key member of our team, you will be responsible for managing clinical trials from start-up through close-out, ensuring that all components of the trial deliverables are executed to specified quality...

  • Senior Director of Clinical Operations

    4 weeks ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...

  • Clinical Development Leader

    4 weeks ago

    Cambridge, Massachusetts, United States Sarepta Therapeutics, Inc. Full time

    The Director, Clinical Development is responsible for leading a clinical sciences team responsible for advancing Sarepta's clinical-stage programs. The individual is responsible for defining strategic priorities for the program and integrating cross-functional input in order to develop and execute the clinical development plan. The individual may be called...

  • Senior Director of Business Development

    1 month ago

    Cambridge, Massachusetts, United States Simcere Full time

    Join Simcere Pharmaceutical Group as a Senior Director of Business DevelopmentSimcere Pharmaceutical Group is a pioneering pharmaceutical company driven by innovative research and development. Our mission is to provide patients with cutting-edge medicines across key therapeutic areas, including oncology, central nervous system, autoimmunity, and infectious...

  • Business Development Director

    4 weeks ago

    Cambridge, Massachusetts, United States MMS Full time

    Job DescriptionMMS is a leading data-focused Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.We are seeking a highly skilled Business Development Director to join our global team and support our business...

  • Associate Director of Process Development

    1 month ago

    Cambridge, Massachusetts, United States Vor Bio Full time

    Unlocking Cancer Treatment through Innovative ScienceVor Bio is seeking an Associate Director/ Director of Process Development to join our Process and Analytical Development group. As a key member of our team, you will oversee the design, development, and characterization of gene edited hematopoietic stem cells (eHSC) and CAR-T manufacturing processes to...

  • Director of Shared Antigen Cancer Vaccine Development

    4 weeks ago

    Cambridge, Massachusetts, United States Moderna Full time

    Moderna Seeks Director, Shared Antigen Cancer VaccinesModerna is dedicated to maximizing the impact of our platform on human health and expanding off-the-shelf (OTS) cancer vaccine discovery and development efforts. We are seeking a talented and motivated Director, Shared Antigen Cancer Vaccines with experience in immune oncology discovery and drug...

  • Associate Director, Analytical Development

    1 month ago

    Cambridge, Massachusetts, United States Adaptimmune Full time

    Job DescriptionAdaptimmune is a leading cell therapy company with a strong focus on innovation and collaboration. We are seeking an experienced Associate Director to lead our Analytical Development work within the Autologous T-cell Process and Analytical Development group.The successful candidate will be responsible for leading analytical assay development,...

  • Analytical Development Director

    3 weeks ago

    Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Lead Analytical Development at Agios PharmaceuticalsAgios Pharmaceuticals is a biopharmaceutical company that empowers connections, fostering a supportive, fun, and flexible environment where employees thrive. We care deeply about our work, each other, and the patients who rely on us. We cultivate strong bonds with patient communities, healthcare...

  • Business Development Director

    1 month ago

    Cambridge, Massachusetts, United States Talent Masters Full time

    Job Title: Director of Business DevelopmentTalent Masters is seeking a seasoned Director of Business Development to lead our skilled nursing liaison team in Maryland. As a key member of our organization, you will drive growth and increase patient census across multiple skilled nursing facilities.Key Responsibilities:Develop and implement strategies to boost...

  • Director of Clinical Operations

    1 month ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    Job SummaryWe are seeking a highly experienced Director of Clinical Operations to lead our Oncology programs. The successful candidate will be responsible for managing clinical programs, overseeing CROs and vendors, and working cross-functionally on clinical operations strategy and related initiatives.Key ResponsibilitiesDevelop and execute clinical...

  • Clinical Director

    4 weeks ago

    Cambridge, Massachusetts, United States Strong Force Staffing Full time

    About the Clinical Director - Home Health OpportunityWelcome to Strong Force Staffing, where we connect skilled professionals with dynamic employers. As a Clinical Director - Home Health, you will oversee clinical operations, ensuring the delivery of high-quality home health services. Your leadership will be instrumental in shaping the future of patient...

  • Senior Director of Analytical Development

    4 weeks ago

    Cambridge, Massachusetts, United States Adaptimmune Full time

    Job SummaryWe are seeking an experienced Associate Director to lead our Analytical Development work within the Autologous T-cell Process and Analytical Development group at Adaptimmune.Key ResponsibilitiesLead analytical assay development, optimization, qualification, and tech transfer to QC team, CRO or CMO partners for clinical stage of T cell Therapy...

  • Associate Director, Biomarker Operations, Clinical Biomarkers

    4 weeks ago

    Cambridge, Massachusetts, United States Moderna Full time

    The Role: Moderna is seeking a seasoned Associate Director to lead the Biomarker Operations group within the Clinical Biomarkers Department. This position will provide strategic leadership to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs.Key Responsibilities:Supervise and lead a team of...

  • Product Development Director

    4 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    About the RoleWe are seeking an experienced Product Development Director to lead our digital health product management efforts. As a key member of our team, you will be responsible for developing and executing product strategies that drive business growth and improve patient outcomes.Key ResponsibilitiesDevelop and execute product roadmaps that align with...

  • Senior Director of Clinical Research

    4 weeks ago

    Cambridge, Massachusetts, United States Pfizer Full time

    Job SummaryThe Senior Director of Clinical Research will lead the development of first-in-man, proof-of-mechanism, and proof-of-concept studies for novel biological and small molecule therapies in respiratory disease programs.Key ResponsibilitiesDevelop disease-specific global networks of investigators and key opinion leaders for trial design, management,...

  • Neurology Assistant Director

    1 month ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    About the RoleMass General Brigham is seeking a highly skilled Registered Nurse to fill the role of Assistant Director for Neurology. This is a temporary position with an anticipated duration of 3-6 months, with the possibility of extension based on clinical needs.The Assistant Nurse Director will play a crucial role in extending leadership presence and...

  • Clinical Sciences Associate Director

    4 weeks ago

    Cambridge, Massachusetts, United States Novartis Pharmaceuticals Full time

    Job Summary:We are seeking a highly skilled Clinical Sciences Associate Director to lead our global clinical trials in oncology and hematology. As a key member of our research team, you will be responsible for driving the development of new treatments and therapies.Key Responsibilities:Lead cross-functional teams to design and execute clinical trials,...

  • Medical Director for Early Stage Clinical Studies

    4 weeks ago

    Cambridge, Massachusetts, United States Stratacuity Full time

    Job Title: Medical Director for Early Stage Clinical StudiesLocation: OnsiteJob Overview: Stratacuity is seeking a Medical Director to assist in the design and implementation of early POC studies, including medical monitoring.Key Responsibilities:Lead and oversee early POC studiesConduct medical review and assessment of adverse event reports, adhering to...

Clinical Development Director

1 month ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
Role Overview:

The Role:

Moderna is seeking a physician to develop, execute, and lead clinical studies supporting one or more development programs in the Infectious Disease department.

Board certification in Infectious Diseases, Internal Medicine, and/or Geriatrics, Pediatrics, or Obstetrics and Gynecology is desirable.

At least 2 years of research and industry experience in vaccine development is highly desirable.



Key Responsibilities:

Provide clinical development expertise and leadership to the clinical study team.
Either directly medically monitor clinical trials or provide medical safety oversight of CRO medical monitors.
Collaborate with partners in the pharmacovigilance department to analyze 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 preparing, analyzing, and presenting safety data to internal and external safety monitoring boards.

Assume primary responsibility for preparing 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.



Requirements:

MD or non-US equivalent of MD degree with completion of residency in Internal Medicine, Family Practice, Geriatrics, Pediatrics, or Obstetrics and Gynecology.

Completion of a fellowship or focused training in Infectious Diseases or Geriatrics is highly desirable.

We can also consider candidates who don't possess an MD, and may instead possess PhD, PharmD, DO, NP, or PA qualifications.

If this is the case, they would also require at least 5 years' experience of working for a pharma or biotech setting, completing similar tasks.

Minimum 2 years' experience in early- to late-stage development in an academic or industry setting.



Key Qualifications:

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).
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.



Benefits:

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 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 (EEO/AAP Employer) -SummaryLocation: Cambridge, Massachusetts; Clinical Development; Bethesda, MarylandType: Full time