VP, Clinical Development, Autoimmune

Company: Moderna Therapeutics
Location: Cambridge
Posted on: May 13, 2022

Job Description:

Moderna is seeking a physician with internal medicine training with pharmaceutical experience to lead Clinical Development for our expanding Autoimmune programs. Moderna has an exciting pipeline of programs interrogating autoimmune diseases, including IL2 and PDL1 nearing clinical stage, with others to follow. We seek an expansive thinker to effectively translate the potential of mRNA into treatment of multiple autoimmune diseases. Experience in a broad therapeutic range of drug development and in mid and late-stage development is a plus. This role will report to the SVP, Head of Therapeutics Development for Moderna and have direct medical responsibility for the clinical development of our Autoimmune portfolio, including accountable for the overall clinical development plans, innovative clinical studies and protocols, and for ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners, Clinical Research Organizations and regulatory agencies. The position is based in Cambridge, MA headquarters. There is approximately 10% travel expected as part of this role. The successful candidate is able to work independently and thrive in a proactive can-do culture and team milieu to lead the clinical development activities for mRNA-based therapies for our current Autoimmune programs while leveraging success in those to catalyze development across the most promising Autoimmune. You will work closely with colleagues in Therapeutics Development including autoimmune disease, Rare Disease, and immuno-oncology, while also having a change to interact with colleagues in infectious disease. The candidates will be a highly effective internal and external team player and terrific communicator and collaborator. Here's What You'll Do: Provide clinical leadership for the Autoimmune Therapy programs across projects, while deeply involved at each project team level, including ensuring most streamlined and innovative clinical development/medical strategy areas. Utilize both internal and external inputs (e.g., academic thought leaders, research leads, regulatory authorities, contract research organizations, investigators and patient groups) Drive innovation in design of clinical development plans and study protocols within the disease area, accessing world-class expertise through external and internal collaboration, harnessing digital, technological and statistical tools and with specific accountability to support early-stage programs in the therapeutic area by bringing in disease insights and clinical research expertise. Responsible for the design and development of clinical development plans, study protocols and interpretation and analysis of clinical study safety and efficacy data, including review of the pre-clinical package. Responsible for Investigator Brochures, Clinical Study Reports, regulatory submissions and responses pertaining to clinical development, and other program documents. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Ensure high quality and timely interpretation of clinical data, including through meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings. Provide Medical Governance with specific accountability for managing and mentoring clinical staff in the disease area line and ensure proper training and compliance with internal and external policies, guidance, laws and codes. Ensure clinical trials adhere to cGCP and compliance with FDA, EMA and other relevant national regulatory agency requirements. - Develop risk-based safety monitoring of clinical trials and implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues. Ensure high quality clinical sections of regulatory documents, prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Committee meetings May participate in due diligence or other business development activity. Contribute in partnership with Research and Development and Technical Development colleagues to design and implement translational strategies. Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development, Research and the broader Moderna organization Represent Moderna externally to investigators, trial site administrators, external funders and sit on Joint Development Committee for programs performed in collaboration with other Pharma companies. Develop and maintain Clinical Development excellence in the therapeutic area through talent identification, recruitment, development and retention, to support the pipeline and marketed portfolio. Here's What You'll Bring to the Table: Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant internal medicine training. Completion of a residency program strongly preferred. Minimum 12 years' experience therapeutics clinical development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials from phase 1 to phase 3. Outstanding verbal and written communication skills, in addition to excellent organizational skills Experience in innovation in clinical development, including clinical trial design, use of digital technology, and understanding of genetics in drug development Understanding of the entire drug development process, including clinical and non-clinical study design, innovative study design platforms, use of digital and importance of target product profile. - Broad understanding of local and global Pharmaceutical industry, competitive landscape, how end-to-end life and revenue cycles operate. Demonstrated ability to lead and inspire teams and allocate resource strategically and according to portfolio priorities. Proven ability to manage and develop self and work collaboratively with others to deliver innovative and creative results and solutions. Includes leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical, medical and epidemiology) Superior stakeholder management skills, across scientific, academic, regulatory and political communities to identify and achieve mutual goals for the well-being of patients and our communities. Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of global clinical studies. Ability to thrive in a fast paced, rapidly evolving environment with little direction. Embodies Moderna's core values of 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 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-KF1 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 , VP, Clinical Development, Autoimmune, Executive , Cambridge, Massachusetts