"Alerted.org

Adecco Healthcare & Life Sciences is hiring an Associate Medical Director for our medical supply and instrumentation partner based out of Cambridge, MA.

The anticipated hourly wage for this position is $103- $105 Hourly.

Summarized Purpose:

Clinical trial physician--pediatrician

Provides clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget .

Essential Functions:

1. Provide medical leadership to the study teams , including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection , contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials

2. Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead

3. Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead

4. Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications

5. Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP

6. Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties

7. In case more than 1 physician is working on the protocol , a primus inter pares will be appointed and he/she will ensure that answers to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonised across medics

Education and Experience:

• MD or equivalent required. Active medical licensure preferred.

• Candidates should have at least one of the following: Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 2 years); Or Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or direct experience in safety/Pharmacovigilance (comparable to 2 years).

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Desired Skills and Experience:

• Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatric, )

• Some experience in industry preferred

• Excellent English, both written and spoken is a must, as well as ability to travel.

• Proven interpersonal skills enabling to lead a study team, while recognising individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately

• Pro-active problem solver with negotiation skills , remaining sensitive to the different cultural needs in a global organisation

• Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,

Comments

- Medical monitoring experience

- Ideally experience at pharma or even better, biotech. CRO experience only not excluded

- Important: solid experience with PIPs (pediatric investigation plan)

- Ideally with some expertise in neurology and/or rheumatology / rare disease

- Must be east-coast US

- Able to travel, max 20%

**Pay Details:** $103.00 to $105.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://uat.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance

**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.