What are the responsibilities and job description for the Senior Medical Director, Clinical Development position at People With Chemistry?

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. The Senior Medical Director, Clinical Development will report to the Chief Medical Officer and provide medical leadership while being hands-on as needed. As a key member of the clinical team, this individual will develop, lead and execute on the clinical development strategy, potentially identify new disease targets for development, and work closely with the company's research team to ensure alignment of clinical and pre-clinical priorities.

The ideal candidate will be a seasoned clinician with a proven track record of driving drug development programs toward registration. The candidate also has a demonstrated track record of working with and developing teams across clinical development, clinical operations, regulatory affairs, biostatistics / data management and medical affairs.

RESPONSIBILITIES :

Build upon the medical vision and clinical strategy to advance Electra's assets for the benefit of patients
Provide clinical leadership across the development spectrum and advance Electra's programs through close partnership with the CMO
Ensure that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines as well as a 'patients first' mentality
Lead clinical data review, analysis, and interpretation from a variety of sources to enable program go / no-go decisions
May serve as Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies
Attend clinical, scientific and investigator meetings representing Electra as a medical expert regarding drug development candidates
Contribute to the preparation of protocols and regulatory documents
Evaluate, select, and develop relationships with key opinion leaders, clinical investigators, and contract research organizations
Contribute to the design and analysis of natural history studies to better understand the company's diseases of interest
Lead within a high caliber, world-class clinical development group
Work closely with the research, translational and commercial functions to prioritize disease indications for proof-of-concept clinical studies
Demonstrate strong people management skills, leading by example and working with teams to manage multiple projects

EDCUATION & PROFESSIONAL EXPERIENCE :

MD / PhD with at least 3 years of biopharmaceutical industry experience to demonstrate knowledge of all phases of drug development, registration and approval

Expertise in developing hematological cancer therapies is required

Strong leadership skills and experience leading cross-functional clinical teams

Experience in both late-stage clinical development as well as translational medicine and early clinical development with success advancing products through the regulatory process

Ability to "think outside the box" and develop strategies for novel trial designs in indications for which precedent trial designs and endpoints may not be available

Working knowledge of GCP, ICH, FDA, EMEA, SFDA, PMDA and other key health agency regulations and requirements to move a product to first in human studies and early to late-stage development

Independent, self-motivated individual with a strong entrepreneurial mindset and "can do" attitude

Proactive, forward thinker with the ability to think innovatively about clinical development and regulatory strategy and accurately anticipate future consequences and trends

Ability to interact and build strong relationships with external Key Opinion Leaders and industry experts in hematology

Ability to operate and thrive in a fast-paced environment; demonstrated flexibility; self-starter, proactive and results-oriented with high performance standards

Ability to assess the feasibility of portfolio programs and create a development plan from First in Human to clinical proof-of-concept to BLA

Willingness to be hands-on and detail oriented while understanding the organization's long-term goals

Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. Ability to develop strong, positive relationships with colleagues and the Board of Directors

Prior line management experience preferred

The salary range for this position is $300,000 - $330,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.

Salary : $300,000 - $330,000

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