Millendo Therapeutics is a publicly traded late-stage biopharmaceutical company based in Ann Arbor, focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. As a leading orphan endocrine company, Millendo creates distinct and transformative treatments where there is a significant unmet medical need.
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Millendo Therapeutics has committed itself to fostering workplace development, diversity, and inclusion (WDDI) at Millendo and across the biotechnology industry. We are dedicated to being at the forefront of efforts to develop a diverse and talented global workforce. To that end, we affirmatively support the following WDDI Principles adopted by the Biotechnology Innovation Organization (BIO), and pledge to do our part to foster diversity and inclusion among our employees, customers, and patients. Link to BIO: https://www.bio.org/diversity
Millendo is a small but rapidly growing biotechnology company whose lead asset, livoletide, is entering a pivotal trial in the coming months. Based on a positive randomized, double blind placebo-controlled Phase 2 study, the company is investing in building the commercial team to provide a competitive advantage in the Prader-Willi syndrome (PWS) space. Millendo plans to commercialize this orphan product in the US by themselves and partner in other geographies. The company is preparing for success by recruiting commercial leadership talent in preparation for rapid growth and eventual product launch.
Millendo is seeking a medical expert (M.D. or D.O.) for assigned clinical trials. This role will provide input into the design and conduct of clinical trials, assessment and interpretation of clinical data, and investigator training.
This role will be based in Ann Arbor, MI
This is a full-time role
- Lead medical aspects of medical monitoring
- Work closely with the CRO’s to provide medical input into safety reports, including SAE narratives and analysis of similar events, Suspected Unexpected Serious Adverse Reaction (SUSAR) reports, Investigator Brochure (IB), Risk Management Plans, Integrated Summary of Safety, Clinical Study Reports, and preparation of labels
- Further clinical development programs by assisting in the design and conduct of clinical trials, including: drafting of protocols and respective amendments, informed consent forms, data monitoring committee charters, and other supporting documents
- Provide medical expertise for assigned clinical trials with the expectation to being readily available to advise on trial-related medical questions or problems during the conduct of the trial
- Contribute to site and investigator training
- Assist in medical reviews, assessment and interpretation of efficacy and safety data to ensure that the data are correct and presented with the appropriate medical interpretation
- Responsible for medical monitor input into the development and implementation of standard operating procedures for all aspects of Adverse Event (AE) report handling, aggregate reporting and assuring compliance with global and local regulatory requirements
- Responsible for implementing alignment across policies/procedures and ensuring that data generated are compliant with FDA and ICH guidelines and GCP.
- M.D. or D.O., experience in endocrinology would be a plus
- 1-3 years of experience in drug development or clinical research, preferably in the pharmaceutical industry
- U.S. and E.U. experience preferred
- Fluent in oral and written English
- Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing
This role reports into the Senior Medical Director and works closely with the Senior Director of Clinical Operations
The Chief Business Officer (CBO) is a key role for Millendo Therapeutics and will be a major contributor in shaping the future success of the company. He/ she will be responsible for identifying, evaluating, as well as negotiating and completing significant business transactions within large pharmaceutical and/or top-tier biotechnology companies to include partnering, licensing, and M&A.
This role will be based in Ann Arbor, MI
This is a full-time role
The CBO must have a broad business orientation and will have responsibility for the following:
- Work closely with the Chief Executive Officer (CEO) and members of the executive team to drive Millendo’s corporate strategy and long-range plan based on the identification of opportunities for internal discovery and product development.
- Seek ex-US commercialization partners for programs.
- Represent Millendo both internally and externally to effectively present to pharmaceuticals and biotechnology organizations the potential benefits from partnering or licensing purposes.
- Design an executive business roadmap of potential partners and opportunities that will enable Millendo to be the leader in Endocrinology
- Lead cross-functional teams to develop technical, commercial and financial assessment of all new business opportunities.
- Monitor competitive intelligence by keeping up to date on market trends, competitors and opportunities.
- Provide regular presentations in various company forums including company and Board of Directors meetings. Ensure that all relevant supporting documentation for transactions (including external presentations, opportunity reports, management presentations, Board memos and other deal communication materials) are of the highest quality and are prepared, reviewed and approved as appropriate.
- Cultivate a strong and effective partnership with R&D team to evaluate the potential new compounds and to integrate a commercial perspective early in the research and development process.
- Advanced scientific degree preferred. MBA a plus.
- Over ten years of business development experience within the pharmaceuticals and biotechnology industry, identifying new products with in-licensing, out-licensing, and strategic partnering opportunities.
- Proven track record of identifying opportunities and, structuring, negotiating and closing transactions including strategic alliances, M&A, licensing agreements, joint ventures, equity investments, etc. In depth knowledge of financial analysis, corporate and product valuation as necessary to engineer such deals.
- Extensive transactional experience with evidence of value creation.
- Deep analytical and financial modeling experience.
- Exceptional communication and influence skills, with the ability to inspire confidence and work successfully with varied audiences including industry partners, financial institutions, Board of Directors, fellow management and employees, with a strong executive presence.
- Entrepreneurial, collaborative, energetic self-starter with strong interpersonal and analytical skills and proven ability to work effectively with a CEO and other senior management as a strategic partner.
- Strong scientific orientation, ideally with rare/orphan or endocrinology therapeutics and can establish and maintain credibility with internal and external scientific and business experts.
- Desire to be part of a team and organization where scientific and business excellence are shared values.
- Ability to work strategically and collaboratively as a member of the management team.
This position reports into the President and CEO and will be a member of the Executive Team.
Millendo Therapeutics, Inc. seeks to hire a new General Counsel and Corporate Secretary (“General Counsel”) to lead the Millendo legal function. The General Counsel will interact frequently with the President and CEO, board of directors and members of the executive leadership team. Millendo seeks an experienced lawyer with relevant industry experience who demonstrates a passion for the business and the Company’s strategies, is aligned with the culture of the organization, and who will inspire, develop and motivate the legal team.
The General Counsel will advise on issues of overarching importance to the Company and will assist in setting and implementing the Company’s overall strategic direction. He/she will serve as the legal advisor to the President and CEO and to the board of directors and will work closely with the President and CEO, CFO and the rest of the executive team to provide counsel on all major initiatives. He/she will also coordinate and manage litigation, will be responsible for supervising Millendo’s complex patent, trademark and other intellectual property portfolio and be expected to oversee Millendo’s eventual transformation into a commercial enterprise. The General Counsel will manage and supervise Millendo’s legal department and work to ensure that Millendo’s legal function operates as a true business partner.
This role will be based in Ann Arbor, MI
This is a full-time role
The General Counsel of Millendo must have a broad business orientation and will have responsibility for the following:
- Actively providing cross-functional advice and counsel on a wide range of legal, regulatory and commercial matters as a key member of the executive leadership team; these issues will include policy formulation, allocation of resources and achievement of the Company’s overarching strategies.
- Advising executive management and the board of directors on matters related to securities compliance and corporate governance, specifically with respect to public company filings and the requirements mandated by NASDAQ, the SEC, The Sarbanes-Oxley and other relevant federal and state securities laws, regulations and rules.
- Guiding and advising the Board and its constituent committees on their responsibilities under the rules and regulations to which they are subject, including corporate governance-related matters.
- Active and engaged counseling on both the business and legal ramifications of significant Company strategic imperatives, including possible acquisitions, divestitures, joint ventures, other possible investments and negotiating and structuring major transactions.
- Advising on the litigation and regulatory risks of possible business decisions; counseling on the appropriate strategies to defend or resolve litigation associated with complex matters, such as intellectual property, antitrust/competition, government investigations and other matters.
- Actively supervising and advising on all aspects of intellectual property and specifically with respect to patent prosecution and litigation and the licensing in and out of technologies; advising on antitrust and international competition laws as they relate to intellectual property.
- Acting as the Company’s Chief Compliance Officer and overseeing the development and dissemination of compliance policies that will ensure that the Company is in compliance with all laws, rules and regulations that may apply to Millendo’s activities; monitoring the regulatory landscape and anticipating changing regulations and policies and their impact on the Company.
- Leading and coordinating the legal services provided by the Company; leading all Company lawyers and employees within the legal department; developing, mentoring and coaching of the legal team; overall administrative and financial management relating to the legal department; choosing and managing outside counsel; establishing procedures for evaluating the quality and cost of services of outside counsel.
- The successful candidate should hold a law degree from an American law school and be a member of the bar, although it is not necessary for the attorney to be a member of any specific state bar. A track record of academic distinction and a law degree from a top tier law school are required.
- Significant executive leadership and managerial experience as the general counsel or deputy general counsel of a publicly-traded pharmaceutical or bio-pharmaceutical company.
- Experience counseling senior executives, boards of directors and their committees and individual board members on a range of legal and governance matters including public company compliance and securities disclosure issues.
- Significant transactional experience.
- Experience supervising complex litigation matters.
- Experience supervising the provision of legal services.
- Experience supervising an effective, business aligned intellectual property law function with respect to the prosecution and litigation of patents and other forms of intellectual property is desired; a deep understanding of the importance of an actively managed intellectual property portfolio of patents as a fundamental corporate asset and the importance of developing a robust patent strategy with respect to the protection of technology and the licensing in and out of technology.
- Experience counseling human resources with employment and executive compensation matters.
This position reports into the President and Chief Executive Officer and will be a member of the Executive Team.