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Head of Clinical Affairs

CDI
Paris
Salaire : Non spécifié
Début : 31 mai 2023
Télétravail fréquent
Expérience : > 10 ans
Éducation : Bac +5 / Master

Implicity
Implicity

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Le poste

Descriptif du poste

⭐️ We need you ⭐️

Reporting to the CEO,
you develop and execute the Clinical strategy for our platform and medical software pipeline, in line with the market access & regulatory requirements, lead clinical research programs with partners & customers and contribute to the definition of the next-generation of Implicity’s solutions,
in collaboration with the CEO / Head of Corporate Development / Head of Product / Head of Data

You manage a clinical project manager

You are part of the company management committee

Here are your responsibilities:

Clinical Strategy

★ Define and implement the clinical development plan required for the regulatory approval process and the market access of our medical device software under development, in line with Date & regulatory roadmap

★ Define & write Implicity’s study protocols (from idea to complete protocol), with insights on methodology & statistics

★ Collaborate with our network of academic medical centers to initiate and support the roll-out of new research programs

Clinical Operations

★ Manage the clinical studies

★ Monitor all external (vendors, investigation centers) and internal interactions required for the implementation of clinical trials within budget, deadlines and applicable regulations

★ Carry out the study set-up (clinical study documents, regulatory submissions)

★ Manage study follow-up

★ Conduct data management, analysis and interpretation of clinical results for regulatory submissions and publications

Transversal Support

★ Provide strong clinical expertise and strategically support Implicity teams in functional areas including R&D, Quality & Regulatory Affairs, Product, Corporate Development, Marketing and Sales

At Implicity, you will have a weekly meeting with your manager, to help you succeed in your mission, and continuously improve your skills.

Each team works with quarterly OKR, to be crystal clear, fair and honest with your targets.

The annual appraisal is shared exchange moment, focused on your development.



Profil recherché

⭐️ You are ⭐️


🥉 Your Background

★ Medical Doctor (M.D.), PharmD, PhD in Biomedical Sciences, Biomedical Engineer or Equally qualified academic healthcare professional

★ Around 10 years of clinical development in the medical device industry and ideally in a MedTech startup

★ Experience in the Cardiac Rhythm Management sector

★ Proven experience & comprehensive knowledge in clinical operations, medical product development process, and roles and responsibilities of individuals within a multi-disciplinary project

★ Proven track record of successfully launching new medical devices in Europe and the USA, ideally medical device software


🥈 Your Hard Skills

★ Extensive knowledge of GCP guidelines / MDR / ISO 14155

★ Medical writing (CEP, CER, Scientific publications)

★ Strong network of professionals in this industry (medical professionals, institutions, researchers, laboratories, CRO…)

★ High level computer skills required, as well as clinical  management tools (e.g. EDC)

★ You are both super fluent in French & in English


🥇 Your Soft Skills

★ Capable of interacting effectively with external contactors and also internally within a multicultural environment

★ Hands-on attitude and focused on driving value

★ Excellent organizational skills along with strong attention to details

★ Enthusiasm and deep belief in the transformative potential of patient remote monitoring devices and technology for the healthcare industry

★ Strong work ethic & daily act with integrity, honesty and fairness

★ Definitely a thoughtful team player, looking to make your colleagues successful. You are convinced that 1+1=3

★ You like this ad, and think this is very like you 😊

It is OK to apply without meeting all the criteria: just honestly tell us why you think you can be THE one.



Déroulement des entretiens

😁 More cool stuff to know about Implicity 😁


💰 Remuneration

★ For this job (CDI - full time), your base salary will depend on your experience

★ Company equity


👍🏻 Benefits

★ Health care plan: Alan (28€ / month + 15,5 for kids)

★ Luncheon voucher: 9€ (50% employer)

★ Transport: 50% of your pass  OR  sustainable mobility pass (38,55€ / month)


Why us?

Simply because you will get all Scale-Up advantages without the usual drawbacks!

★ Activity: we are a “purpose company”  -  that really drives everyone’s daily motivation and commitment

★ Solution: we built a best-in-class solution, that has no direct competitor

★ Growth stage: we are not small - we are not big - we are 100  =>  our boom is to come

★ International: we operate at a global level, and our working language is English

★ Values: we do have values, and these are not just for posters!
   . Integrity: we act with honesty and fairness
   . Ambition: we strive for excellence in a healthcare demanding environment
   . Cooperation: we care, we support, we seek collective success

★ Autonomy: you’ll definitely get real responsibilities, and have the chance to have impact

★ Employee care:
  . Our beautiful office is “rue du Louvre” (between Chatelet & Bourse)
  . Regular team events, especially every Thursday evenings

★ Tools: we used Slack, Notion and DropBox, and it is pretty cool

★ Remote: up to 3 days / week

★ Worklife balance: we are definitely respectful

★ Shareholder: you will be incentivized with company equity

Do you need more arguments? We’ve got a bunch!


🤓 Want more infos?!

★ Our website: https://www.implicity.com/about-us/

★ Our team: https://www.welcometothejungle.com/fr/companies/implicity/team

★ Our other opening jobs: https://www.implicity.com/careers/

★ Our cool grade on Glassdoor: https://www.glassdoor.fr/Pr%C3%A9sentation/Travailler-chez-Implicity-EI_IE4010545.16,25.htm

★ Our $23M Series A last January 2022: https://www.implicity.com/ressource/seriesa/

★ A cool article by La Tribune: https://www.latribune.fr/technos-medias/innovation-et-start-up/la-startup-de-la-semaine-implicity-previent-les-crises-cardiaques-grace-aux-donnees-829691.html

★ And finally, 2 interviews of our CEO Arnaud Rosier:
. https://www.youtube.com/watch?v=1ofIQQMWqZo
. https://www.bsmart.fr/video/1727,37-ecosysteme-implicity


🙏🏻 Let’s Meet 🙏🏻

★ If you believe that you are the right person for Implicity, we are looking forward to receiving your application through the Implicity page on “Welcome To The Jungle” website

★ We are proud to be an equal opportunity employer. We constantly challenge ourselves to build a diverse team of talents and to create an inclusive environment for all employees

★ Recruitment process:
   10-15min call with Pierre Maindivide (Head of People)
  Interview with Arnaud Rosier (CEO), your future manager
  Interview with members of the leadership team : Issam Ibnouhsein (Head of Data)  and/or  Caroline Florequin (Head of Quality & Regulatory Affairs)  and/or  Julien Durand (Head of Product)
  Same as 3°

\=> Depending on your availabilities, the recruitment process should last less than 2 weeks.

Offer usually follows within 48 hours 🤞🏻

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