Medical Director, Clinical Development
Amylyx PharmaceuticalsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- MD, PhD, or PharmD required
- Experience in clinical development is required
- Experience in rare diseases or neurology is highly preferred
- Proven ability to work with cross-functional teams, study vendors, and clinical trial sites
- Strong business communication skills, written and verbal, and comfortable giving presentations internally and externally
- Thorough understanding of GCP/regulatory requirements
- Proactiveness – ability to identify challenges and risks and implement appropriate actions with some supervision
- Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
Responsibilities
- Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
- Lead development of clinical sections of trial and program level regulatory documents
- Drive execution of the program and/or clinical trial in partnership
- Support the Clinical Development program lead by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contribute to/driving development of disease clinical standards for new disease areas
- Conduct literature review, KOL interactions, attend scientific meetings, and present the clinical development plan to relevant internal stakeholders to help shape the new indication selection process
- Lead the protocol development for the new selected indication/s, working closely with relevant external and internal stakeholders
- As a medical specialist, support and lead interactions with external and internal partners and decision boards
- Perform medical monitoring of the assigned clinical trial/s, data and safety review, and work closely with clinical operations and external partners to oversee conduct of the assigned clinical trial/s
- Work closely with internal and external stakeholders as well as clinical sites and investigators to help ensure timely recruitment
- Steer the preparation, review, and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports
- Review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide data interpretation and data mining
- Ensure assigned studies are conducted according to GCPs and SOPs
- Act as the medical monitor in close collaboration with the CRO medical and clinical monitors
- Oversee/guide conducting literature searches and reviews, meta-analyses, and publishing data
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is remote work allowed for this position?
Yes, the company is open to you working remotely.
What experience is required for this role?
You must have experience with Rare Diseases or Neurology within the biotechnology or pharmaceutical industries.
What is the salary or compensation for this position?
This information is not specified in the job description.
What is the company culture like?
The company is building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.
What makes a strong candidate for this role?
A strong candidate will have experience in Rare Diseases or Neurology in biotech or pharma, along with skills in clinical leadership, protocol development, KOL interactions, and GCP compliance.
Abata Therapeutics
Develops therapies for autoimmune diseases
About Abata Therapeutics
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.
Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees