Millendo Therapeutics is a venture-backed pharmaceutical development company based in Ann Arbor, Michigan developing novel therapies for endocrine diseases of hormone dysregulation. The company focuses on orphan and underserved endocrine indications that are aligned with internal expertise. The company seeks to develop multiple indications through Phase 2 within the next few years.
We are looking for talented individuals to join our team. Please view our current job openings and submit your resume to firstname.lastname@example.org for consideration.
Job Duties and Responsibilities
The Vice President, Clinical Development will be responsible for a broad range of development activities including the creation of clinical development plans across several indications. The candidate must have experience across all phases of drug development in multiple therapeutic areas. A proven history of successfully leading development programs to registration is required, along with experience in direct interactions with regulatory agencies (FDA and EMA). The candidate 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. The candidate must have the ability to function independently as the Clinical line functional lead, while working collaboratively and partnering with other line functions. Experience and success in working with external vendors (e.g., CRO) is required. The role requires the candidate to serve as deputy to the Chief Medical Officer on occasion and must have the ability to comfortably interact across the company and with external stakeholders. Specific responsibilities include the following:
- Work collaboratively with other stakeholders (i.e., Nonclinical, Commercial and Regulatory) to identify and assess feasibility of additional indications for lead compounds, including developing the strategic path and clinical study designs from proof-of-concept through Phase 3.
- Assess the feasibility of combination therapies for portfolio compounds and create a development plan from Phase 2 to NDA/sNDA.
- Develop publication strategies to launch, in partnership with the Commercial line function, including a detailed plan for publications in scientific journals as well as presentations at scientific meetings.
- Develop and build Key Opinion Leader relationships to support programs and indications.
- Provide Medical/Clinical support for Phase 1 studies. Provide medical monitoring support for the ongoing Phase 1 study working closely with the clinical operations team.
- Serve as clinical/medical representative for identifying and assessing in-licensing opportunities, providing due diligence on clinical aspects.
- M.D. or D.O.
- A minimum of 10 years of relevant clinical drug development experience in a role with direct Phase 1, 2 and 3 clinical trial responsibility
- Experience in Endocrine, Oncology or General Medicine indications is a plus
- Previous experience working with CROs is required
Required Competencies – Knowledge, skills, and abilities
- Strong written and verbal communication skills
- Exceptional interpersonal skills
- Team-oriented and a strong team player
- Proven track record of leadership and management skills
- Comprehensive knowledge of GCP/ICH guidelines
- Highly organized with exceptional attention to detail
- Able to work in a dynamic, changing environment
- Demonstrates honesty, trustworthiness, fairness, cooperation, self-control and flexibility
This position reports to the Chief Medical Officer and is eligible for benefits. Millendo Therapeutics is headquartered in Ann Arbor, Michigan.
Millendo Therapeutics 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. 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.