The Vice President, Head of Clinical Development, will report to the Chief Medical Officer and be a member of the Development Leadership Team, the Development Review Committee and Portfolio Strategy Committee.
- Working closely with the Head of Clinical Science, present clinical strategy plans and clinical data to the Executive Leadership team and the Board of Directors
- Provide overall clinical scientific leadership for the entire clinical portfolio including direct responsibility for clinical development strategy, design and oversight of execution of clinical trials
- 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 their direct reports multi-disciplinary teams charged with guiding (early) clinical development and subsequent regulatory submissions
- Directly manage and mentor a team of Medical Directors
- Serve as the primary representative for the therapeutic area to a range of audiences, including executive leadership, development partners, including but not limited to Gilead
- Chair or core member of various Joint Development and Joint Steering Committees and US and global regulatory agencies
- Bay-Area located and willingness to work in the office at least 3 days per week highly preferred. 'Face-to-face is king mentality'. For remote candidates, working in PST time zone is non-negotiable and willingness to come to Brisbane office 1 week per month is required
- MD or MD/PhD and Board eligible or centerfield oncologist or foreign equivalent (medical-, surgical-, radiation-oncology)
- 10+ years of biotech and/or pharma oncology drug experience
- Has working knowledge of GCP, ICH, US FDA and EMEA regulations
- Successfully conducted exploratory clinical and/or confirmatory development
- Early development, FIH/ FIP, phase 1 dose escalation and proof of concept experience and late-stage experience is required in solid tumor oncology and immune-oncology.
- Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
- Experience designing and developing smaller, yet robust and innovative platform trials, randomized phase 2 and registrational Phase 3 programs.
- 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.
- Effective 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 and understanding of pre-clinical development.
- Experience in working with external collaborators, including CROs, national institutes and multinational pharmaceutical companies is preferred.
- Strong analytical and problem-solving skills, is well organized has mastered complex medical/clinical development tasks
- Superior written and verbal communication skills within scientific presentation, corporate and clinical team and clinical trial environments
- Works effectively under pressure and has rigorous work ethics with focus on details and high-quality results
- Ability to work in matrix environment (dotted-line authority), 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 to meet challenges and develop original ideas
- Available to travel (up to 20% of work time)
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 $262,000 - $420,000 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