Medical Director, Early Phase and PK - Durham - Definium Therapeutics

    Definium Therapeutics
    Definium Therapeutics Durham

    1 week ago

    Description

    Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

    Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient‑centric, intelligent individuals.

    This role is U.S. based, fully remote.

    The Medical Director Early Phase and PK plays a pivotal role in shaping the early phase clinical development strategy for the company's candidate molecules. As part of a multifunctional team partnering with Clinical Operations, Clinical Pharmacology, Nonclinical, Regulatory, Biostatistics, and Pharmacovigilance to ensure high-quality data and alignment toward safe and successful product development, they serve as the medical SME on assigned FIH, Phase 1, and Phase 2 trials, weighing in on clinical trial design and eligibility, data monitoring and reporting.

    Responsibilities:

    • Bring medical and scientific expertise to the design, execution, and interpretation of FIH, Phase 1, and Phase 2 clinical studies ensuring patient safety and scientific integrity
    • Author and oversee key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs). Respond to health authority and IRB inquiries for respective studies
    • Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross‑functional collaboration
    • Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations. Collaborate with Pharmacovigilance to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
    • Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, manuscripts, regulatory interactions)
    • Contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables. Interact with investigators as needed, assist in site selection, and support training of sites at study start‑up

    Qualifications:

    • Advanced degree (M.D., D.O, D.N.P, Ph.D. etc.) required
    • 3-5 years of clinical development experience within contract research, pharmaceutical, or academic settings, with a focus on early‑stage development or translational research
    • Experience designing and running clinical pharmacology studies (preferred), or studies with PK and PD endpoints in healthy volunteers and/or patient populations
    • Ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH‑GCP and global regulatory standards
    • Strong communication and collaboration skills, with the ability to influence and partner effectively across cross‑functional teams, investigators, and external experts
    • Highly organized with the ability to manage multiple priorities in a fast‑paced, evolving environment

    The starting base pay range for this position is $218, $246, Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

    • 100% paid health benefits including Medical, Dental and Vision for you and your dependents
    • 401(k) program with company match and vesting after the turn of the first month after your start date
    • Flexible time off
    • Generous parental leave and some fun fringe perks

    #J-18808-Ljbffr
  • Work in company

    Medical Director, Early Phase and PK

    Only for registered members

    We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals. · This role is U.S. based, fully remoteThe Medical Director Early Phase and PK plays a pivota ...

    Durham $218,583 - $246,810 (USD)

    2 weeks ago

  • Work in company Remote job

    Medical Director, Early Phase and PK

    Only for registered members

    We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. · ...

    Durham, NC

    2 weeks ago

  • Work in company Remote job

    FSP Principal Biostatistician- Early Phase Clinical Development(PK)

    Only for registered members

    The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases of development, focusing on healthy normal studies with PK and PD endpoints. · ...

    Durham, NC

    1 month ago

  • The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases of development. · ...

    Durham

    2 weeks ago

  • Work in company

    Senior Science

    Only for registered members

    Come build something with Shepley Bulfinch as a Healthcare Space Planning Lead. · ...

    Durham

    1 month ago

  • Work in company

    Research Assistant Professor

    Only for registered members

    Summary Of Position · The position will be responsible for the leadership and administrative management of the New Hampshire Maine Leadership Education in Neurodevelopmental Disabilities Programs ( LEND ) and administration of grants and contracts in early intervention and early ...

    Durham $80,000 - $120,000 (USD) per year

    6 days ago

  • Work in company

    Senior Space Planning Architect

    Only for registered members

    · Come build something with Shepley Bulfinch as a Healthcare Space Planning Lead  · As a Senior Science & Technology Space Planning Lead, you will serve as a key collaborator in creating innovative and client-centered design solutions. This role requires a forward-thinking archi ...

    Durham, NC

    19 hours ago

  • Work in company

    research scholar

    Only for registered members

    This is a Research Scholar position in the laboratory of Dr. David MacLeod at Duke University. · ...

    Durham $50,000 - $105,000 (USD) per year

    6 days ago

  • Work in company

    Manufacturing Associate

    Only for registered members

    Job Description · The Manufacturing Associate is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. Additionally, must ensure all work is conducted following Good Manufacturing Pra ...

    Durham

    6 days ago

  • Work in company Remote job

    Therapeutic Strategy Director

    Only for registered members

    We are looking for a Therapeutic Strategy Lead who is experienced in Oncology global clinical trial development and can support customer engagement and responses to proposals. · Leverage IQVIA medical, scientific, operational and data science experts to determine the optimal solu ...

    Durham, NC

    1 month ago

  • Work in company Remote job

    Therapeutic Strategy Director

    Only for registered members

    The Cardiovascular space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for early engagement and to create a winning strategy. · ...

    Durham, NC

    1 month ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    We are looking for a Therapeutic Strategy Lead who is experienced in Cardiovascular global clinical trial development and can support customer engagement and responses to proposals. · The ideal candidate is an experienced consultative leader responsible for driving early engageme ...

    Durham $114,900 - $319,900 (USD)

    1 month ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    Job Overview · The Oncology space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for early engagement and to create a winning strategy. · We are looking for a Therapeutic Strategy Lead w ...

    Durham $114,900 - $319,900 (USD)

    1 month ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    We are looking for a Therapeutic Strategy Lead who is experienced in Cardiovascular global clinical trial development and can support customer engagement and responses to proposals. To be successful in this role, it is important to understand Cardiovascular disease clinical trial ...

    Durham $114,900 - $319,900 (USD) Full time

    1 month ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    JOB OVERVIEW · The Cardiovascular space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for early engagement and to create a winning strategy. We are looking for a Therapeutic Strategy Le ...

    Durham, North Carolina, United States of America $114,000 - $319,000 (USD) per year

    6 days ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    JOB OVERVIEW · The Respiratory space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for early engagement and to create a winning strategy. We are looking for a Therapeutic Strategy Lead ...

    Durham, North Carolina, United States of America $139,000 - $259,000 (USD) per year

    6 days ago

  • Work in company

    Physical Metallurgist

    Only for registered members

    Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, and automotive powering a high-technology future. Vulcan Elem ...

    Durham

    2 days ago

  • Work in company

    Senior S

    Only for registered members

    Come build something with Shepley Bulfinch as a Healthcare Space Planning Lead. · 10+ years of professional experience · Prior experience with institutional architecture academic research science & technology · ...

    Durham, NC

    1 month ago

  • Work in company

    Physical Metallurgist

    Only for registered members

    Physical Metallurgist  · Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, and automotive powering a high-techn ...

    Durham Full time

    2 days ago

  • Work in company

    Product Manager

    Only for registered members

    We are seeking a results-oriented individual to join our Infrastructure Solutions organization to deliver supremely innovative products and grow our ecosystem partnerships in support of revolutionizing cooling solutions for AI datacenters. · This role is responsible for defining ...

    Durham $80,000 - $140,000 (USD) per year

    1 week ago

  • Work in company

    Therapeutic Strategy Director

    Only for registered members

    Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. · The Respiratory space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for ...

    Durham, NC

    1 month ago

Jobs
>
Durham