Director/Senior Director, Clinical Development

Viela Bio, Inc. Gaithersburg , MD 20877

Posted 2 months ago

Viela Bio is looking for a talented and highly motivated Clinician to join our team. This position will have full responsibility for the planning, implementation and daily operation of drug development projects. He or she will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

Key Responsibilities:

  • Will be responsible for delivery of development projects.

  • Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.

  • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.

  • Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.

  • Present and defend protocols and clinical development plans at internal governance forums.

  • Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II/III studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.

  • Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.

  • Present study updates, interim results, and final headline data to senior management as required.

  • Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).

  • Ensure that Serious Adverse Events are properly reported on a global basis.

  • Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.

  • Implement clinical R&D policies, SOPs and related directives.

  • Review potential in-licensing candidates and present recommendations to Senior Management groups.

  • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.

Desired Skills and Experiences:

  • Experience:

Director

  • 3-5 years' experience in clinical research and/or drug development in CRO, pharmaceutical environment, or academia

Senior Director

  • 5 plus years' experience in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
  • Good understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.

Education:

MD with a valid US medical license preferred. Thorough understanding of immunology and sub-specialty training in an area related immune mediated diseases (e.g. autoimmune diseases, neuroimmunology, transplantation) strongly preferred.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Svp Clinical Development

Emergent Biosolutions

Posted 1 week ago

VIEW JOBS 1/12/2021 12:00:00 AM 2021-04-12T00:00 Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The incumbent will be responsible for the development, execution, operation, and management of the Clinical development strategy and programs for Emergent's rapidly expanding drug development, therapeutics, device and vaccine portfolios. This includes oversight and management of Clinical Development, Clinical Operations, Biostatistics, Data Management, Bioprogramming and Pharmacovigilance Functions. ESSENTIAL FUNCTIONS * Lead a team of over 100 FTEs + contractors to drive the development and execution of multinational clinical program strategies, studies and trials, aligned with Business Unit and Corporate Strategies. * Ensure that scientific rigor, creativity and innovation are upheld in all clinical initiatives and contribute to senior level discussions assessing development strategies, business development opportunities and commercial plans. * Clearly communicate and translate program strategies into clinical studies across all Phases of clinical development and oversee execution. * Manage the related budgets, program costs, external vendor contracting and other associated business/clinical interfaces. * Provide clinical and medical oversight for project teams, regulatory agency interactions, business units, manufacturing and other stakeholders for vaccine, therapeutic and device development. * Collaborate with internal and external partners, investigators and KOLs to design and implement clinical studies. * Provide leadership for clinical operations, data management, pharmacovigilance, and biostatistics as well as involvement in global regulatory matters. * Oversee and contribute to drug development strategic plans providing technical and strategic advice to meet milestones and budget. * Translate findings from research and non-clinical studies into clinical development opportunities through portfolio management. * Ensure that all studies are conducted all Clinical activities in accordance with accepted medico-legal and ethical standards and pharmaceutical industry guidance. * Continue to build a team and team structure that can successfully support the execution of strategies and programs within the department currently and as the portfolio of programs expands. * Develop and build talent within the Clinical Development team through coaching, mentoring and providing inspirational leadership. * Ensure people development is a priority for the function and the diversity of functions within the Clinical Development Group. * Contribute to Business Development discussions and decisions regarding new technology assessment and asset acquisition plans. * Partner across the breadth and depth of Emergent to contribute to the matrix structure and communication paradigms. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS * PhD, PharmD, or MD with a proven track record of taking candidates through all phases of clinical development and licensure. * 15 or more years of experience in clinical development as a Head of Function in biotechnology or pharma. Late stage development experience (large molecules) is a plus. * Prior experience in successfully building teams and developing talent across clinical development, clinical operations, data management and statistics. * A team builder who is able to coach and mentor team members and work closely with employees on their continued development. * Develops and maintains good relationships, gains the confidence of others and works effectively in a multidisciplinary matrix environment. * Strategic thinker with creative and excellent problem solving and decision-making skills. * Resilient self-starter, who can act independently and learn quickly within a rapidly evolving environment * Excellent communicator with strong interpersonal skills and demonstrated experience managing remote and/or global teams. * Excellent analytical skills with an ability to critically interpret and use scientific and clinical data to manage risk assessment * Able to effectively collaborate with other departments and external clients and vendors. * Ability to manage multiple tasks with deadlines in a fast-paced working environment * Perceptive, creative, and innovative with the ability to contribute new ideas and to build consensus. * Experience in global regulatory requirements and guidelines pertaining to drug safety * High attention to detail and accuracy with a strong commitment to business ethics. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES * Stand shoulder to shoulder no matter what * We combine our best thinking and communicate openly to support each other. * Break through thinking * We take smart risks, pursue innovation and challenge ourselves to constantly improve. * Own it always * Every person at Emergent is engaged and accountable for delivering on our commitments. * Compete where it counts * We set the right goals and respect each other as we conquer them together. Emergent Biosolutions Gaithersburg MD

Director/Senior Director, Clinical Development

Viela Bio, Inc.