Description
SummaryThe Senior Vice President, Head of Clinical Development, will report to the Chief Medical Officer and be a member of the Development Senior Leadership Team, the Development Review Committee and Portfolio Strategy Committee. Responsibilities
- Working closely with the other development functions, present clinical strategy and clinical data to the Executive Leadership team, business partners, and others
- Provide overall clinical scientific leadership for the entire clinical portfolio including direct responsibility for clinical development strategy, design and oversight
- Provide input into early development strategy and planning starting at candidate selection, working close with our preclinical development and research teams
- Lead, directly or through direct reports,multi-disciplinary teams charged with guiding clinical development from phase 1 through phase 3
- Directly manage and mentor a team of Medical Directors
- Chair or core member of various Joint Development and Joint Steering Committees with business partners
Qualifications
- MD or MD/PhD and oncology trained (Board eligible or certified)or foreign equivalent (medical- or surgical- oncology)
- Extensive biotech and/or pharma oncology drug development experience, strongly prefer BLA or NDA filing experience
- Working knowledge of GCP, ICH, US FDA and EMEA regulations
- Early development, FIH/ FIP, phase 1 dose escalation and proof of concept experience, and late-stage experience are required in solid tumor oncology
- Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle
- Experience designing and developing smaller, yet robust and innovative platform trials, proof of concept or randomized phase 2, and registrational Phase 3 studies
- Prior experience interacting effectively and successfully with regulatory agencies is essential, across the spectrum on FIH/IND, end of phase 2/ pre-phase 3 and (s)NDA/(s)BLA
- Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required.
- Proven ability to represent the Company’s interests effectively in interactions with external partners, investigators, and regulatory agencies
- Ability to lead a dynamic group in a fast-paced and hands-on environment
- Strong written and verbal communications and interpersonal skills with all levels
- Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making across various development functions
- Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions
- Experience in working with external collaborators, including CROs, academic institutions, and other pharmaceutical companies
- Strong analytical and problem-solving skills, and has mastered complex medical/clinical development tasks
- Works effectively under pressure and has rigorous work ethics with focus on both details for high-quality results, and clear view of the big picture
- Ability to work in matrix environment, lead by influence, accurately, amiably and effectively work with teams and CROs, foster commitment in team members (including those in CROs), build successful collaborations with internal and external partners
- Able to manage clinical trial resources, clinical trial budgets, identify human resource needs, make appropriate prioritizations and plans to resolve challenges
- Available to travel (up to 25%)
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment.
Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. This role can be based at our Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $420,000 - $450,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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