Senior Medical Director

About the company

The company Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At the company, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The company’s team is inspired to touch and help change lives through the company’s clinical studies in the field of oncology. The company has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

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HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). The company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials a BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.    They will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.

The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams.    This position will provide medical insight across a myriad of functions from discovery to manufacturing are expected.  Additionally, the Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training.    Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment.     The Medical Director will serve as a leader on one multiple potentially pivotal programs.

Role and Responsibilities

• Significant Oncology Experience the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of the company medicines to benefit patients

• Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications

• Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals

• Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning)

• Manage direct reports or cross functional team members as needed based on team needs

• Contribute to the communication strategy of the company products via publications, manuscripts, abstracts, posters and scientific presentations

• Making vital contributions on pivotal programs in clinical development program

• Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals

• Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals

• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and  government, regulatory, or partner agencies

• Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders

• Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review

• Planning, reviewing and editing Clinical Study Reports

• Planning, reviewing and editing publications from the program

• Providing input on the design of clinical studies supporting clinical strategy

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development

• Minimum of 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology

• Working knowledge of clinical development pathways for hematology/oncology the company in the US and EMA

• Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission

This is the pay for this position

Pay Transparency

$253,000 — $317,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

The company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the company’s Talent Acquisition team at  [link for members]  to obtain prior written authorization before referring any candidates to the company.

The company Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.