Associate Medical Director, Clinical Research
$225,500 per year
ApplyAssociate Medical Director, Clinical Research
Posted yesterday
SENIORITY
Manager
SALARY
$225,500 per year
About the role
- Demonstrate ownership of the design and implementation of a clinical protocol that supports the product development plan, based on strong medical and scientific principles. An emphasis on hematological malignancies is preferred
- Provide clinical and medical input to protocols, regulatory documents, publications, and site/investigator interactions especially in complex patient cases
- Respond to site questions related to eligibility, concomitant medication assessments, dose modification guidance, and provide investigator medical support
- Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data
- Conduct study support, data review and query of sites, and provide scientific leadership with clinical research scientists
- Present at scientific, medical, and regulatory meetings globally
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups
- Contribute to company’s planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents
- Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing- the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders
- Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
- Maintain ethical standards of the highest level and have the knowledge and ability toundefined
- As required by program needs, contribute to partnership with Discovery colleagues to the design and implementation of translational strategies
- Participate in meetings and committees of parent company or other affiliates.
- Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates.
- Work in close collaboration with the late-stage development group
- Perform other duties as requested.
- Key Core Competencies
- Ability to run a complex clinical research program with some direction
- Extensive knowledge of hematological malignancies is preferred
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
- Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive
- Able to lead through influence
- Excellent communication and presentation skills are essential.
- Identify the key competencies or attributes required to excel in the role.
- Examples may include problem-solving, teamwork, communication, etc.
- Highlight any specific qualities or traits that are important for success in the role.
- These could include attention to detail, adaptability, creativity, etc.
- Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MDCompletion of a residency program strongly preferred
- Completion of a subspecialty fellowship is desirable
- Experience in blood cancers or solid tumors desirable0 to 3 years of pharmaceutical drug development experience required.
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