Director/Sr Director, Clinical Project Management

Location
94080, South San Francisco
Posted
Jul 24, 2018
Required Education
Bachelors Degree
Position Type
Full time

Director/Sr Director, Clinical Project Management

Antiva Biosciences, Inc. is a privately held San Francisco Bay Area-based biopharmaceutical company focused on the development of antiviral therapies.   The company is using a new medicinal chemistry platform to develop antiviral therapies, focusing first on HPV.  Antiva has additional molecules that target HIV, the herpes virus, cytomegalovirus and others.  Antiva’s lead compound, ABI-1968 is a topical antiviral for the treatment of human papillomavirus (HPV) infections, the primary cause of cervical and anal cancer. We are seeking an exceptional Director or Sr. Director, Clinical Project Management to take on a leadership role within our Clinical department and partner with CMC to provide cross-functional project support.  This position will report directly to the Chief Medical Officer and have responsibility for developing and managing the clinical development plan and support cross-functional activities of ABI-1968 in all indications.

Specific Responsibilities include (but are not limited to):

  1. Co-ordinate planning activities for clinical development of topical ABI-1968 in both CIN and AIN indications.   Support overall budget and timeline projections for upcoming studies.    Support CMO and Clinical Operations in assessing and managing clinical study risks, feasibility analysis, scenario planning, resource management and outsourcing strategy.  Partner within Clinical Operations, Biostatistics, Regulatory and other functions to optimize clinical trial planning and implementation. 
  2. Partner with the Head of Project Management to incorporate and update clinical timeline and budget into overall product development plan:

a.     Drive overall clinical development plans by managing goals, milestones, timelines, and budgets that align with corporate and project strategies

b.     Monitor study progress and communicate to stakeholders. Identify and manage risks and issues that may affect successful clinical plan

c.      Anticipate, identify, and resolve discrepancies in project priorities, plans, and activities in a timely fashion

d.     Manage clinical meetings, including setting agendas, facilitating and documenting meetings, and issuing meeting minutes. 

e.     Facilitate resolution of issues within the team and with external partners (i.e. CROs, etc)

Requirements

  • Position requires a Bachelor of Science degree and at least 10 years pharmaceutical industry experience specifically in human drug development.  Position also requires demonstrated experience in the global drug development & management of complex clinical development programs.  Experience in planning global trials is required. Experience in antiviral/HIV, Gyn or topical products is a plus. Higher degree (PhD, PharmD, MBA) is preferred. Ability to incorporate CRO timeline and deliverables into Antiva’s development plans timelines.  Excellent verbal, written communication and presentation skills. Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team and to effectively support multiple activities in a fast-paced environment. Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines. Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task to be able to thrive in small company environment. Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action. Proven track record of successfully delivering clinical projects on time, within budget and at the required quality. Experience managing program in clinical development stage.    Ability and willingness to effectively manage conflicts and achieve results.  Willingness to travel as necessary, consistent with program needs.

Antiva provides very competitive benefits and compensation plans including incentive based compensation as well as a collegial, collaborative, entrepreneurial environment committed to improving global health outcomes for individuals with HPV related diseases.

Qualified candidates may submit their resume to careers@antivabio.com