Senior Director Regulatory Clinical
Location: Remote, Experience: 15 years, Type: Full-time Exempt
Reports to: Chief Regulatory Officer
Vaxxinity is a clinical-stage immunotherapeutic company formed through the combination of COVAXX and United Neuroscience, two independent subsidiaries of United Biomedical (one of the leading vaccine companies in the world consisting of seven operating entities). Led by a female CEO, in an informal values-driven start-up culture, Vaxxinity will control half a dozen development candidates targeting neurologic disorders, hypercholesterolemia and COVID-19. Vaxxinity is currently pre-selling and ramping up production and distribution for hundreds of millions of COVID-19 vaccines.
You will collaborate with a group of inspiring colleagues all over the globe who are working on disruptive projects, solving big problems and having a huge impact on the world. Vaxxinity is an international company, operating remotely from day one across several countries and team members worldwide. Expect to grow, expect to be challenged, and expect the unexpected as we embark on this journey of democratizing health for all the world’s citizens.
We are searching for a polished, smart, passionate, caring, self-motivated Senior Director Regulatory Clinical. The ideal candidate brings wisdom, enthusiasm, integrity, focus and perspective to oversee and direct all clinical strategies for all products. The Senior Director provides guidance and support to internal groups such as Clinical, Nonclinical, Marketing, as well as to outside groups such as our partner United Biomedical to ensure consistent global regulatory plans and strategies to expedite licensure of our vaccine candidates. The Senior Director also provides strategic input and risk assessments and oversees preparation of regulatory submissions, interacts with regulatory agencies selects, develops, and evaluates personnel to ensure the efficient operation of the function. This position will eventually build a Regulatory team that will support the Clinical/Nonclinical strategies for both the Neuroscience and Infectious Disease vaccine portfolio.
- Serve as a Regulatory Clinical Project Lead and provide Clinical Regulatory leadership within Regulatory and on cross-functional teams.
- In depth knowledge and application of global regulatory guidelines regarding investigational new drug (IND)/biologics license applications (BLAs) or post approval changes.
- Accountable for the delivery of all regulatory milestones for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity.
- Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation according to defined timelines.
- Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to senior management.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities.
Education / Experience
- BS or MS in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.
- At least 15 years of relevant Regulatory experience; with a focus on vaccine development.
Knowledge / Skills / Abilities
- Clever, flexible and resourceful -- must be able to work independently and know when/how to ask for help.
- Ability to stay calm, cool, and focused in stressful times and maintain a professional demeanor.
- Highly motivated, a “roll-up-your sleeves” attitude to work requirements, able to multi-task and meet rigorous timelines.
- Excellent project management and prioritization skills including ability to handle multiple tasks and work in a fast-paced, time-sensitive environment.
- Excellent communication skills in a wide array of situational settings from c-level interaction to core team members, imparting both vision and execution focus; deep analytical skill sets with a synthetic mindset.
- Proven high level capability to concisely communicate complex and controversial issues and drive to resolution.
- Be science-driven
- Communicate clearly, openly and respectfully
- Unite in teams and collaborations
- Learn and help others learn
- Act with integrity
- Get she*t done