Job Details
Please read the job description in full before submitting your resume.
Candidates who do not have the right to work and reside in the US will not be considered (no sponsorship).
You must be an MD and have industry experience to be considered.
Contract opportunity: 12-months renewable.
This is a hands-on requirement, and as an individual contributor, will report into the SVP/ Head of Clinical Development.
Senior Medical Director will be an internal program lead for one or more of the clinical programs. This role will be essential to the overall strategic leadership of the clinical program, generation of development plans, trial design, trial conduct, data analysis and/or medical monitoring of clinical studies based on a thorough understanding of the mechanisms of target function and drug candidate activity. Strong academic background and training is desired and the candidate will be supported by internal staff and external consultants as needed based on the ebb and flow of the workload. Experience in drug development in hematologic malignancies is strongly preferred.
Duties and Responsibilities:
- Clinical Development Plan generation from first-in-human trials to regulatory approval with cross-disciplinary support
- Appropriate development strategy and trial design driven by target function, mechanism of drug candidate action and understanding of disease profile and patient tumor characteristics.
- Identification of clinical investigators and KOLs based on target and disease knowledge; coordination of their activities for trial conduct, advisory boards, etc.
- Translation of trial design into protocol development (first-in-human through Phase 3), including writing and reviewing protocols/informed consents in conjunction with colleagues from other disciplines (eg, Nonclinical Sciences, Translational Sciences, Clinical Pharmacology, Clinical Operations and Statistics)
- Guidance for clinical data review, analysis and presentation (including writing and/or review of clinical study reports, abstracts, presentations and manuscripts)
- Protocol implementation, including interactions with clinical teams
- Support for trial initiation and conduct (eg, IRB responses, CRF and database reviews)
- Clinical monitoring to ensure the highest standards for patient safety, trial conduct and data integrity
- Interaction with and support of Regulatory function to ensure timely contribution of clinical sections for IND, IB, NDA and other communications with the Agency
- Timely and accurate safety reporting to regulatory authorities
- Program development, including cross-functional interactions with appropriate disciplines to achieve programmatic goals
- Close interaction with appropriate functions to ensure that the scientific basis for targeted therapies under development and emerging data inform therapeutic strategies and biomarker exploration in current and future trials
- Management of external colleagues who serve in consulting roles
- Interaction with regulatory authorities, as needed
Qualifications:
- MD or MD/PhD (PhD in a scientific discipline is preferred) from accredited institution(s)
- Board certification (or foreign equivalent) in at least one medical specialty; formal training in Medical Oncology and/or Hematology and/or extensive oncology clinical development experience is preferred
- Significant experience or exposure to immunology and/or cancer immunology is strongly preferred.
- Patient care experience for at least 3 years after obtaining MD, including residency and fellowship training
- Experience in oncology/hematology clinical development
- Experience in small biotech highly desirable
- Ability to work independently, with direction and within project teams
- Excellent verbal and written communication skills; comfortable with public speaking
- Strong organizational skills, including the ability to prioritize workload
- Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel (e.g., medical, scientific, and manufacturing staff, as well as consultants)
- Skilled in the use of MS Word and power point in order to prepare outlines, summaries, status reports and slides for presentation
- Ability and willingness to travel up to 20% of the time (international and domestic)