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Company Overview:

Millendo Therapeutics is a venture-backed pharmaceutical development company based in Ann Arbor, Michigan developing novel therapies for endocrine diseases with significant unmet need. The company focuses on orphan and underserved endocrine indications that are aligned with internal expertise.

We are always interested in receiving resumes of talented individuals. If you are interested in sending us a resume, please submit it to careers@millendo.com.

 

Chief Development Officer (CDO)

Role Description
This role is responsible for supporting the Company’s vision to rapidly deliver new and transformative medicines to patients with endocrine diseases. To that end, the CDO will be expected to contribute to the Company’s continual drive to maintain and further a passionate culture dedicated to rapidly developing its portfolio while maintaining the highest standards of ethics and professionalism. The CDO will have overall ownership and responsibility for product development in partnership with the Chief Medical Officer, and will coordinate critical functions necessary for assembly and approval of high quality regulatory approval submissions, including providing strategic leadership and project management for Millendo’s product candidates (nevanimibe and livoletide) . The CDO will also oversee Project Management, Regulatory and CMC functions, both in terms of delivering operational excellence and setting strategy for the growth of each functional area.

Responsibilities

  • Facilitate the success of Millendo’s development activities in all product indications. 
  • Work closely with the CMO and leadership team to identify key milestones and critical paths to ensure that program goals are met in a timely manner.
  • Create and implement consistent and transparent processes that drive high quality planning and key decision making across all development disciplines.
  • Instill a culture of balanced risk management and creativity to ensure development teams provide options to exceed program timelines.
  • Identify opportunities to expedite programs (e.g. by performing functions in parallel or making strategic investments).
  • Troubleshoot and solve problems under aggressive timelines while maintaining high standards of quality.
  • Lead the development programs and teams in a manner that ensures operational success of the teams they in turn manage.
  • Be a key contributor to decision making regarding acquisition of new product opportunities.

Requirements
The ideal candidate for the Chief Development Officer role is a proven leader with a strong track record in strategic project management and operations leadership with a minimum of 10 years’ experience in the biotech or pharmaceutical industry. A record of accomplishments managing all the aspects that are associated with pre-NDA and NDA development through approval is highly preferred.

Key requirements include:

  • PhD, MD or MD/PhD in a scientific discipline is desired but not required.
  • Excellent strategic and project management skillset with drug development programs.
  • Successful industry track record in overseeing multiple drug development programs within various therapeutic areas.
  • Sophisticated scientific skills and business judgment with an ability to innovatively address product opportunities, evaluate alternatives, establish priorities and apply resources effectively.
  • Ability to provide strategic leadership to Project Management, Regulatory Affairs and CMC functions.
  • Highly developed understanding of the external marketplace to identify long-term benefits for unmet patient needs. 
  • Strong external presence with excellent communication skills and industry reputation.
  • An understanding of Millendo’s pipeline and future growth prospects combined with the ability to communicate to the scientific community regarding those opportunities. 
  • Individual performer but also excellent team-player within the executive team.
  • Credibility within the international scientific communities.
  • A proven track record as a builder and leader of exceptional scientific project management teams.

Reporting Relationships
This position reports into the CEO. It will work closely with the Chief Medical Officer. Direct reports include the Project Management, Regulatory Affairs and Chemical, Manufacturing and Controls (CMC) functions.

Millendo offers an excellent compensation package, including comprehensive benefits and the opportunity to work in a challenging and rewarding environment.

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, national origin, age, disability or genetics or their protected veteran status, sexual orientation or gender identity and will not be discriminated against on the basis of disability.

Senior Scientist, Analytical Chemistry

Job Duties and Responsibilities
This position will be part of the CMC organization and have responsibilities for managing Millendo Therapeutics’ external CMOs from development through commercialization. Specific duties for this position include the following:

  • Monitor activities at CMOs; provide technical support and troubleshooting
  • Review and approve analytical technical documents such as protocols and reports
  • Write, review and QC CMC regulatory documents
  • Assist with budgets, forecasts and timelines to implement CMC strategies
  • Manage contracting process
  • Manage inventories

Desired Education, Experience and Skills

  • Education
    • B.S., M.S., or Ph.D. required, preferably in chemistry
  • Experience
    • Two or more years in the pharmaceutical industry with focus on CMC activities
    • Knowledge of CMC regulatory guidelines and cGMP
    • Experience with CMOs preferred
    • Experience preparing CMC documentation for regulatory filings preferred
    • Experience with clinical supply chain management preferred
  • Skills/Competencies
    • Strong written and verbal communication skills
    • Exceptional interpersonal skills
    • Team-oriented and a strong team player
    • Strong sense of urgency and ownership, and a team player
    • Well-developed organizational skills
    • Outstanding written and verbal communication skills
    • The ability to solve complex scientific/technical problems
    • Eagerness to learn and do what it takes to get the job done well

This position reports to the Vice President, Chemistry Manufacturing and Controls.

Millendo Therapeutics is headquartered in Ann Arbor, Michigan. Millendo Therapeutics offers an excellent compensation package, including comprehensive benefits and the opportunity to grow in a challenging and rewarding environment.

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, national origin, age, disability or genetics or their protected veteran status, sexual orientation or gender identity and will not be discriminated against on the basis of disability.

Vice President, Medical Affairs

Job Duties and Responsibilities
The Vice President, Medical Affairs will be responsible for overall global medical affairs strategy to support the Company’s product candidates across all indications. A key part of this role will be to develop strategies to support the strategic brand imperatives and key messaging. This includes developing the clinical story, evidence generation and publication plan, KOL engagement plan, approach to scientific congresses, and oversight of future phase IV/observational studies and registries. The successful individual will be responsible for establishing the direction and approach for medical affairs across all current and future product lines while collaborating closely with the Clinical Development and Commercial Development line functions. The candidate must be a proven medical affairs expert, having worked across multiple therapeutic areas ideally including rare/orphan indications, and must have excellent interpersonal skills and possess the ability to interact and build strong relationships with Key Opinion Leaders across multiple therapeutic areas. Experience with strategic publication planning and supporting pre-launch activities is a strong plus. Specific responsibilities include the following:

  • Provide overall management responsibility and leadership for the company’s medical affairs activities including meeting corporate goals and objectives and keeping in compliance with applicable policies and regulations.
  • Develop and lead a comprehensive medical affairs strategy including such activities as the formation of Advisory Boards, Educational Programs, and Scientific Conferences, in collaboration with the commercial organization.
  • Develop and lead a comprehensive publication plan/strategy as part of the larger medical affairs strategy in collaboration with the commercial organization and the non-clinical organization.
  • Implement consistent and transparent processes that drive high quality planning on decision making.
  • Establish and maintain Key Opinion Leader (KOLs) relationships to support ongoing indications and future indications, including potential Investigator Initiated Trials (IIT).
  • Build and expand Millendo’s relationships with patient advocacy groups.
  • Create and execute on the growth plan for the Medical Affairs line function within Millendo.
  • Provide Medical/Clinical support for Phase 1 studies as the need may arise.
  • Possess understanding of government and industry guidelines, regulations and laws for appropriate scientific/medical exchange and communication with customers.
  • Ability to work in a dynamic, changing environment with an exceptional attention to detail.
  • Ability to demonstrate honesty, trustworthiness, fairness, cooperation, self-control and flexibility.
  • Instill a culture of balanced risk management and creativity to ensure development teams provide options to meet or exceed program timelines.

Desired Education, Experience and Skills

  • Education
    • M.D. or D.O.
  • Experience
    • A minimum of 10 years of strong leadership skills and proven biopharmaceutical industry experience in leading medical affairs, ideally within the context of a rare/orphan drug.
  • Skills/Competencies
    • Strong written and verbal communication skills
    • Exceptional interpersonal skills
    • Team-oriented and a strong team player
    • Proven track record of leadership and management skills
    • Highly organized with exceptional attention to detail
    • Able to work in a dynamic, changing environmen
    • Demonstrates honesty, trustworthiness, fairness, cooperation, self-control and flexibility

This position reports to the Chief Medical Officer.

Millendo offers an excellent compensation package, including comprehensive benefits and the opportunity to work in a challenging and rewarding environment.

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, national origin, age, disability or genetics or their protected veteran status, sexual orientation or gender identity and will not be discriminated against on the basis of disability.