Title: Chief Development Officer

Reports To: CEO/Board of Directors

Key Accountabilities:

• Prepare development strategy;
• Execute development plan project management;
• Hire clinical testing partners;
• Recruit and manage roster of development-related consultants;
• Manage stakeholders (internal and external); and
• Deliver clinical trials, successful regulatory submissions, licensing input.

Location: Toronto, Canada

The Company Profile

Antibe Therapeutics - www.antibe-therapeutics.com - is a privately held, early stage, global drug development company with offices in Canada and affiliate laboratories in the USA, United Kingdom, Italy and Brazil. The Company's pipeline consists of drugs targeting serious chronic diseases, including inflammatory bowel disease, erectile dysfunction, irritable bowel syndrome, pulmonary hypertension and various complications of diabetes.

Antibe's unique drug development platform involves the assimilation of small vasoactive /immunomodulatory components to existing drugs to generate new chemical entities that are significantly improved over the parent molecules and/or serve unmet medical needs.

Candidate Profile

The Position:
  
Antibe requires the Chief Development Officer to provide leadership and direction in development planning and execution for Antibe as it grows the enterprise to become a leader in drug development using its unique platform.  The future incumbent is the crucial link between research, design, development, regulatory and licensing for Antibe.  This role is responsible for building out, leading and managing a development team and spearheading the clinical development initiatives with Antibe’s pipeline of drugs.

Combining knowledge of science, regulatory environments, clinical testing and business, the future incumbent will work with key stakeholders to ensure the optimum development planning and execution of Antibe’s drugs at different stages of the development process in various global jurisdictions.  This leadership role supports Antibe’s business strategy and aligns all licensing, marketing and regulatory initiatives.   This role requires the future leader to drive business results by planning and managing multiple projects run by teams of world class scientists and consultants (and stakeholders) located and working virtually, at various sites.   This role requires entrepreneurial leadership, fierce intelligence, resourcefulness, creativity, and tenacity to manage both internal and external stakeholders across geographical jurisdictions and to deal with highly sensitive regulatory and cultural imperatives.  The Chief Development Officer will work closely with the President/CEO and Board of Directors to guide development, and will provide internal expertise to The Company for all development and business development matters.  All of this must be done while remaining effective within a de-centralized “start-up” business model.

Responsibilities and Objectives of the Position

Development:

• Preparing and adapting the development plan to reflect the company’s business strategy;
• Aligning/integrating strategic development, approval and commercialization of each drug in development for jurisdictions of commercial interest;
• Delivering clinical development results with speed, quality and economy for clinical trials and regulatory submissions;
• Formulating clinical development input as part of all drug life cycle management initiatives in multiple jurisdictions;
• Providing recommendations to the President/CEO and Board of Directors on key business strategies such as budget, overall staffing, major tactical programs, contracting strategy, drug licensing and any issues posing significant business risk; and
• Provide a single, integrated development voice to the executive.

Leadership:

• Defining and managing project critical path activities and timelines;
• Ensuring appropriate staffing and management in a lean, distributed infrastructure:
o Hiring and managing clinical testing partners;
o Recruiting and managing a roster of development-related consultants;
o Hiring and managing functional reports, as development team grows;

• Responsible and accountable for development budget and resourcing to support drug development (including tracking all OPEX and CAPEX) and communicating any significant  budget changes to the CFO, CEO and Board;
• Supporting cross functional initiatives among development team, Chief Science Officer and scientific team and regional regulatory consultants to integrate development goals and achieve development and licensing objectives and identification of new product opportunities;
• Interfacing with third party clinical laboratories to establish clinical trial standards and protocols as well as overseeing clinical trial activities including obtaining all necessary regulatory approvals according to domains required; and
• Maintaining strict adherence to quality guidelines, including FDA regulations and participating in the establishment of SOP’s, QA/QC department and initiatives.

Stakeholder Engagement:

• Developing appropriate network to ensure development support for commercial activities, e.g.:
o Key Opinion Leader (KOL) contacts;
o Investment analysts;
o Advisory boards;
o Promotional reviews;

• Interacting with regulatory agencies, contract agencies and collaborators, as needed to achieve development goals;

• Representing the drug development group externally in scientific presentations, conferences and industry groups.

Candidate Requirements

The successful candidate will be passionately dedicated to the process of drug discovery and development, driven by team success and respectful of the “good-science” culture of the organization.  The future incumbent must understand that this is a “start-up” fast-growth organization, so resourcefulness will be necessary.  Previous experience with well established enterprises may serve as a foundation of knowledge and experience for this fast paced role, however, the future incumbent must have an appetite for creating a new drug development company.  He/she will have the following qualifications, experience, skills and personal profile.

Qualifications:

• Ph.D. in a scientific discipline is preferred with 10 years' experience in global drug development in a biotech/pharmaceutical industry; and
• Possess exceptional scientific and leadership skills, and be recognized as both a strong functional development leader, and a leader of major cross-functional projects or corporate initiatives.
 
Experience:

• Clear understanding of the overall drug development process from pre-clinical to NDA/BLA submission and market;
• Pharmacology and molecular development experience in Phases 1 through 4;
• In-depth knowledge of current drug development strategies and technologies, as required, and demonstrated successful leadership is essential;
• Success in transitioning drug development projects from feasibility to the market place, including interactions with the FDA and/or other regulatory agencies as required; 
• Demonstrated experience in working with and leading stakeholders, including internal discovery research and product development scientists, senior company management, the CEO, the Board of Directors, and other external stakeholders including consultants, partners and investors;
• Led, or contributed as a key member of a global team; and
• Proven track record of achieving objectives, successful project completion, within projected budgets and timeframes.

Skills and Competencies:

• Leadership: Able to lead and influence peers, superiors, and subordinates. Possesses excellent team-building skills and judgment in selection of key talent.
• Planning/Analytical Skills: Demonstrates a probing, analytical, process-orientated approach to create “out of the box” sound solutions.
• Execution: Proven excellent project management skills.
• Communication: Highly effective written and verbal communicator, negotiator, and influencer, team builder, skilled in conflict management and resolution.
o Able to communicate and solve problems across disciplines, borders, and functions.
o Able to effectively interface with all levels of management, staff, and outside company contacts, to include investors, thought leaders, advisors and board members.
• Resourcefulness: Able to use previous experience to determine best commercial routes and access to appropriate professional resources.

Personal Attributes:

• Fosters excellent relationships and credibility internally and externally and is able to effectively influence others in new and existing environments;
• Demonstrates personal conviction and initiative with a relentless focus on building an entrepreneurial success-oriented drug development culture based on respect and mutual accountability; and
• Is comfortable working in a small, market-driven emerging growth R&D environment with limited infrastructure.

Compensation

Excellent total compensation including strong base salary/bonus and highly rewarding stock option component reflecting this unique opportunity.

Send Resumes to:

Patrick Kielty
pkielty@boyden.com