Chief Medical Officer

Role Description 

Millendo is seeking a Chief Medical Officer who can strengthen the management team and bring strategic leadership to the clinical development organization.  Reporting to the President and Chief Executive Officer (CEO), this individual will ensure the flawless execution of clinical programs, including leading NDA filings, and execute on the strategic approach to maximize the value of livoletide and nevanimibe. S/He will serve as an executive team member and partner to the senior management team in developing and implementing Millendo’s overall corporate strategy and eventual transition of the Company into a fully commercial enterprise. 

The CMO will be deeply scientific in their approach to development, will be patient centric and possess a sense of urgency in executing first-in-class clinical studies.  This individual will possess the skill to communicate effectively with a number of constituents, including members of the executive team, patients and patient advocacy groups, key opinion leaders, investors, the Board of Directors, potential corporate partners, and regulatory agencies.

This will be a high profile and high impact position, responsible for executing and delivering on critical clinical milestones. This individual will be an integral medical spokesperson for Millendo, partnering with the CEO and CFO to raise additional capital, interact with KOL and patient advocacy groups, and eventually transition the Company into a fully commercial enterprise.  The person hired for this position will, therefore, be a major leader of Millendo, and have significant influence shaping the future of the Company.

Location
The preferred location for this position would be Ann Arbor, MI or Lexington, MA, however there can be can be some flexibility around relocation if the candidate can commute regularly to Millendo’s headquarters in Ann Arbor.

Responsibilities

• Work closely with the Board, the CEO and other members of the leadership team to make strategic decisions and provide leadership in defining Millendo’s product pipeline, disease areas of focus and translational research approaches.
• Draft and/or review and approve clinical and regulatory documents, including protocols, investigator brochures, study reports and regulatory submissions.
• Lead the process to filing and approval of Millendo’s Phase 3 programs, and subsequent post-marketing activities.
• Partner in developing a communication strategy which presents the value of Millendo’s products to prospective prescribers and payers.
• Articulate our clinical and regulatory strategies and progress to an external audience including investors and analysts.
• Build and foster relationships with patients, Key Opinion Leaders and patient advocacy organizations around the flow of scientific and clinical developments as they relate to drug development strategy and tactics.
• Optimize clinical trials against safety, cost, therapeutic efficacy and endpoints, and accelerate the forward movement of pipeline compounds. 
• Ensure that all processes related to patient safety in the conduct of clinical trials are strictly adhered to; identify early signals for targeted events/outcomes, propose appropriate responses to such signals, and when necessary, pharmacovigilance activities in the pre- and post-marketing environments.
• Communicate and participate effectively with regulators; guide presentations to Advisory Committees and respond to regulatory queries on products submitted for approval, including milestone development meetings.  These include involvement in a series of potential accelerated development paths being discussed with both the FDA and EMA.
• Develop and articulate Millendo’s mission to diverse constituencies such as those at scientific meetings, in targeted peer reviewed publications, with investors, Board members and other important forums for the company.
• Build and manage ad hoc Clinical Advisory Boards.
• Liaise appropriately with external partners. 
• Identify, attract, develop and retain best in class development talent.
• Aid with the utilization of patient registries, development of natural history studies, and fostering an advocacy community for rare genetic causes of obesity.
• Partner in identifying and building new research and development programs for Millendo to expand the breadth of the company’s research, development, and commercial activities.
• Other duties to support the CFO and VP, Finance as needed.
• Directs the activities of one or more cross-functional areas and/or external service providers.
• Consistently promote collaboration, positivity, accountability and resourcefulness.

Requirements

The ideal candidate will possess a minimum of 15 years of experience in biopharmaceutical clinical development with at least ten of those years in a leadership role. An M.D. is required, and while we are open to evaluating candidates with broad therapeutic area experience, exposure to orphan diseases or metabolic disorders and/or endocrinology is ideal but not essential. Additionally, experience working with small patient populations and advocacy groups is preferred.  This physician will bring global experience (at the minimum in the US and EU) across all phases of development, will have previously led at least one NDA filing and approval, and be able to serve in a leadership role in clinical development.  Also important would be experience in the area of medical affairs.  The Chief Medical Officer will have a strong understanding of late stage product development, including clinical trial management, post-launch marketing, post-approval studies, regulatory affairs and GCP. The candidate must have excellent oral and written communication skills as well as the ability to build cross-functional relationships and work collaboratively with other groups, both internally and externally.

Specific Qualitifcation include:

• Proven track record in KOL/investigator relationship building as well as patient advocacy groups.
• Skilled in managing and motivating a clinical development and medical affairs team, ideally for an emerging biopharmaceutical company.
• Strategic but still hands-on; proven ability to succeed in an entrepreneurial company.
• Hands-on, self-starter who will be an assertive and active participant with ability to work in a fast paced, dynamic and collaborative environment.
• Demonstrated commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
• Absolute accountability and commitment to delivery of results. 
• Able to multi-task across a broad range of activities and a strong sense of priorities.
• Driven to progress programs and timelines at very rapid speeds and to drive extraordinary accomplishments.
• Willingness to try new ideas and accept the potential “failure” that comes from that process.
• Able to leverage a myriad of outside resources and collaborate effectively.
• Extremely collaborative with strong executive team.
• Able to look up and see the “strategy,” not just the tactics.
• Strong sense of priorities; someone who earns trust by committing to and delivering results.

We are an equal opportunity employer (EOE). We respect individual differences, embrace diversity throughout the organization, and value the unique strengths of each employee. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity and/or gender expression, national origin, age, disability, genetic information or veteran status.