Vice President, Clinical Development
- Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. The Vice President, Clinical Development, reports to the Chief Medical Officer, and will be a key member of drug development team, responsible for overseeing clinical development of our portfolio, helping to determine the strategy with efficient study implementation and execution across clinical development.
- Lead and oversee an integrated clinical development team to drive and execute the clinical development strategy forward with an eye towards study implementation excellence, cross functional collaboration and innovation.
- Provide a vision of excellence in Clinical Development, in terms of standards, process and performance, and create and refine a clinical development strategy with a road-map for implementation.
- Clearly communicate and translate program strategies into clinical study concepts and support and mentor a systemic execution.
- Provide clinical and medical oversight for project teams, regulatory agency interactions, business units, manufacturing and other stakeholders.
- Collaborate with internal and external partners, investigators and KOLs to design and implement clinical studies.
- Monitor US, EU and Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
- Represent the company in various external forums as needed. Through outstanding communication skills, help to increase the profile of the company.
- Build mutually respectful and collaborative working relationships with other key functions.
- MD/PhD/PharmD with minimum 15 years of experience in Pharmaceutical industry in at least two therapeutic areas across phase I-IV, with at least 7 of these years in Clinical Development,
- An experienced leader who has successfully managed high performance cross-functional teams, worked in a matrix structure, with the ability to translate strategy into clear operational objectives.
- Demonstrate managerial skills to lead teams through change, especially growth, and ensure all actions taken are in line with the company culture of respecting the individual.
- Led a multi-site, multi-function global organization of significant size and complexity. Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent. Uses sound judgement in hiring decisions.
- Has the gravitas, confidence and executive presence to operate with business leaders. Has scientific credibility and business acumen.
- Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, EU, Japan).
- Excellent verbal and written communication skills and collaborative interpersonal skills.
- Anticipates future trends accurately and has a broad knowledge and perspective of regulatory implications on clinical development.
- Consistently achieves results. Pursues everything with energy, drive, and the need to finish. Persists in the face of challenges and setbacks. Always keeps the end in sight; pushes self and helps others to achieve results.
- Ability to lead a cross functional team through influence. Achieves this influence and level of leadership through maintenance of the highest levels of integrity and trust. Builds and sustains excellent relationships at multiple levels within the organization and with external key stakeholders such as federal regulatory agencies, clinical investigators, academics, and others.
- Decisively makes high-quality decisions, even when based on incomplete information in the face of uncertainty. Actively seeks input from pertinent sources to make timely and well-informed decisions. Skillfully separates opinions from facts and considers many perspectives objectively. Is respected by others for displaying superior judgement.
- Deals constructively with problems that may not have clear solutions or outcomes. Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty.
- Assumes the responsibility for the outcomes of others. Promotes a sense of urgency and establishes and enforces individual and team accountability. Is completely on top of what is going on and knows where things stand. Provides balanced feedback at the most critical times. Establishes clear responsibilities and processes for monitoring work and measuring results.